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Medical equipment industry

Heart Patients Face Difficult Decision Over Faulty Defibrillators

Strategic Insights

— 1 min read

Thousands of patients are faced with the difficult decision of whether to keep a faulty Guidant Corp. defibrillator or to have it removed and replaced due to a potential risk of equipment failure. The devices, which can cause cardiac arrest, have been recalled by the company after it was discovered that one model, the Ventak Prizm 2 DR Model 1861, had an electrical flaw that could cause it to short-circuit. Patients like Pam Alexson and Douglas Parsons are sharing a similar emotion: a sense of betrayal that Guidant did not disclose the problem earlier so that some people might have been spared the tough choice they now face.

Key Takeaways:

  • Over 29,000 defibrillators are affected by the recall, with about 17,000 still implanted with the affected Prizm 2 DR devices and 11,900 still implanted with the affected Renewal devices.
  • The surgery to replace a defibrillator takes about an hour, but carries a risk of infection, with about 10 days of recovery time.
  • Patients' decisions on whether to replace the device are highly personal, based on their age, health, dependency on the device, and attitudes toward risk.
  • Patients are also concerned about the potential loss of trust in the company and its products, with some choosing to replace their devices with those made by competitor Medtronic Inc.
  • Johnson & Johnson, which is attempting to acquire Guidant, is trying to determine whether the issue could materially hurt Guidant's business, potentially allowing it to pay less for Guidant or walk away from the deal.

Statistics:

  • About 17,000 people are still implanted with the affected Prizm 2 DR devices, made before April 2002.
  • About 11,900 people are still implanted with the affected Renewal devices, made before last August.
  • The surgery to replace a defibrillator takes about an hour and typically requires 7-10 days of recovery time.
  • About 13,900 of the 17,000 people with the affected Prizm 2 DR devices are in the United States.
  • About 6,700 of the 11,900 people with the affected Renewal devices are in the United States.

Sources:

  • Guidant Corp.
  • Food and Drug Administration (FDA)
  • Johnson & Johnson
  • Medtronic Inc.
  • The New York Times: Robert Spencer, Michael J. Okoniewski

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