Safety Alerts and Recalls on Heart Devices : ICDs

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Safety Alerts and Recalls on Heart Devices
ICDs Pacemakers.
Presevter Emanuel 09-11-2001
CIS
763 PRESENTATION BC/CUNY
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Objective   To present an overview on the topic
of hardware and software errors in the safety
alerts and recalls of pacemakers and ICDs.
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ICDs PACEMAKERS WHAT ARE THEY? An ICD
(implantable cardioverter defibrillator) looks
much like a pacemaker. It is "implanted", or put
in your body surgically. Whereas pacemakers can
speed up a slow heart rate, ICD therapy generally
slows down a fast heart rate. It is like a
small computer that runs on a battery. Or,
ICDs are high-tech devices that contain
sophisticated detection algorithms and tiered
therapy options. The ICD system consists of an
ICD , one or two leads , and a programmer . A
typical ICD is often four to five ounces in
weight, less than two inches wide and a half-inch
thin. The device is roughly the size of four to
five silver dollars stacked on top of one another.
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St. Jude Medical
? PACEMAKER
Guidant
Medtronic
Biotronik
ICD ?
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The term "pacemaker" is used for a small,
battery-operated device that helps the heart beat
in a regular rhythm. Some are permanent
(internal) and some are temporary (external). It
can replace a defective natural pacemaker or
blocked pathway.
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Programmers A programmer enables a physician to
evaluate an ICD's performance and change its
settings non-invasively.
PR-3500 Programmer
For example St. Jude Medical CRMD's
proprietary software enhances ICD function,
offering comprehensive diagnostic capabilities.
It uses a Pentium-processor-based programmer .
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WHY I MIGHT NEED AN ICD? Normally, your heart
has a natural pacemaker that helps your heart
beat steadily. You may need an ICD if you have
had, or are at high risk of having, certain heart
rhythm problems. SOURCE
http//familydoctor.org/handouts/270.html
ARE ICDs USED WIDELY? Japan Airlines Purchases
130 Automated External Defibrillators From
Cardiac ScienceAirline to Outfit All
International Flights With AEDs SOURCE
PRNewswire 9-30-2001 About 900,000 people in
the USA, including Vice President Cheney, wear
pacemakers or ICDs1
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RECALLS AND FIELD CORRECTIONS DEVICES -- CLASS
II ________ PRODUCT Medtronic Implantable
Cardioverter Defibrillators a) Medtronic Micro
Jewel II Implantable Cardioverter Defibrillator,
Model 7223CX b) GEM DR Model 7271 Implantable
Cardioverter Defibrillator. Recall Z-261/262-0.
CODE All serial numbers of the Model 7223CX
Serial Numbers PIM200002R through PIM302777R and
PIM400352R, PIM400968R, and PIM400969R of the
Model 7271 Defibrillators. MANUFACTURER
Medtronic Med Rel, Inc., Humaco, Puerto Rico
Medtronic, B.V., Kerkrade, European Service and
Technology Center, The Netherlands Medtronic,
Switzerland Manufacturing Operations, Tolochenaz,
Switzerland. RECALLED BY Medtronic, Inc.,
Minneapolis, Minnesota, by letter dated August
1999 for the Model 7223CX Defibrillators and by
letter dated December 1999 for the Model 7271
Defibrillators. Devices having capacitor charge
times above a certain level are being
reprogrammed. Firm-initiated field correction
ongoing. DISTRIBUTION Nationwide and
international. QUANTITY Approximately 28,000
units were distributed. REASON Some of the
devices have extended charge times for the high-
voltage capacitors used to store the charge for
cardioversion and defibrillation therapies.
RECALL
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ANY STUDIESYES !
CASE 1
Krannert Institute of Cardiology Case.. A
70-year-old patient experience an acute
dizziness, and was found to have a loss of
ventricular output due to an internal software
problem. This was corrected by software
programming via the programmer. Comment Although
this article was written to exemplify the
potential ability of correcting new generation
ICD software problems non- invasively, it does
not minimize the importance of a life-threatening
software failure.
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CASE 2
Brigham and Women Hospitals Study Context  Unan
ticipated pacemaker and ICD generator
malfunctions sometimes warrant recall by the US
Food and Drug Administration (FDA).
Objectives  To determine pacemaker and ICD
generator advisory rates in the United States, to
identify trends in these rates, and to examine
their clinical and financial implications.
Design and Setting Analysis of weekly FDA
Enforcement Reports issued between January 1990
and December 2000. Recalls and safety alerts
involving lead malfunctions were not included.
Main Outcome Measures Number of pacemakers and
ICD generators in the United States subject to
FDA recall or safety alert in 1990-2000
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• Results of Study
• During the study period, 52 advisories, involving
  408 500 pacemakers and 114 645 ICDs were issued.
• Hardware malfunctions and computer errors
  accounted for 95 of device recalls
• Implantable cardioverter-defibrillators were
  recalled more frequently than pacemakers.
• Between 1995 and 2000, the annual advisory rate
  increased for both pacemakers
• An estimated 1.3 million device checks and
  analyses and 36 187 device replacements resulted
  from the advisories and cost approximately 870
  million.

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• COMMENTS RECOMMENDATIONS
• Nearly 20 of pacemaker wearers could not live
  without one
• Hardware problems and computer programming errors
  were the most common basis for recalling both
  pacemakers and implantable defibrillators.
• "Some (flaws) are potentially life-threatening
  and require device replacement," says William H.
  Maisel, MD, MPH of BWH of Harvard Medial School.
• Kim Eagle of the University of Michigan Medical
  Center said in an accompanying editorial that
  routine recalls are not unexpected "in a
  free-market society that highly rewards profit
  and attends to safety primarily through its
  violation."
• Eagle called for
• A longer testing period for pacemakers.
• Closer regulation of the testing process.
• The creation of a better "device tracking system"
  involving "more parties than industry alone."
• By studying devices that fail, researchers might
  learn how to improve their reliability.
• Source USATODAY
  Healthscience News August 14, 2001

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CONCLUSION Pacemaker and ICD recalls and safety
alerts occur frequently, affect many patients,
and appear to be increasing in number and rate.
Improve the methodology of reporting these
flaws. Remedy for these failures should be
improved hardware/software engineering methods.
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SOURCES Coppess MA, Miller JM, el.  Software
error resulting in malfunction of an implantable
Cardioverterdefibrillator. J Cardiovasc
Electrophysiol 1999 Jun10(6)871-3 Maisel WH,
el. Recalls and safety alerts involving
pacemakers and implantablecardioverter-defibrillat
or generators.  JAMA. 2001 Aug
15286(7)843-4  Kaczmarek RG, Beaulieu MD,
Kessler LG. Medical device tracking results of
a case study of the implantable
cardioverterdefibrillator.  Am J Cardiol 2000
Mar 185(5)588-92 Eagle KA. Safety alerts
involving device therapy for arrhythmias. JAMA.
2001 Aug 15286(7)843-4.
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The End !