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U.S. Department of Health and Human Services

Case Study 2 – Device Product Problem


Donald P. (DOB 4/24/36), a retired autoworker with a wife of 39 years and three children, received XYZ Devices’ 3210 implantable heart defibrillator in January 10, 2006 after going into cardiac arrest while working in his garage. He is a lifelong smoker, 2 packs a day, and has struggled to quit. Donald is currently receiving follow-up care with Dr. Madison at the Cardiac Center, where his implantable heart defibrillator is checked each month.

In October 2009, 3 ½ years post-implantation, during a routine monthly check of Donald’s implantable defibrillator, the nurse, Barbara Caswell, noticed a decrease in the patient’s R wave. Three months later (January 2010), during another monthly check, Ms. Caswell performed a conversion test of the device to check the effectiveness of the lead, due to the continued decrease in the R wave reading. During a visit the following year, the R wave reading was down further to 2.8. At that time, Ms. Caswell informed the doctor of the reading who made arrangements for the lead to be replaced. Donald returned to General Hospital where his initial surgery was done and on March 15, 2011 had the lead replaced. Ms. Caswell submitted a report of the product problem to MedWatch, noting the model number, 3210, and serial number, XH456789.

Two months after the lead problem was reported to MedWatch, Dr. Madison received a “Dear Doctor” letter at the Cardiac Center from XYZ Pharmaceutical. In the letter, the manufacturer describes known problems with the leads of their implantable heart defibrillators. The silicone used to insulate the leads is prone to abrasion causing instances of oversensing, undersensing, loss of capture, changes in pacing, and even inability to deliver a necessary shock. The failure rate for silicone insulator leads is 0.34%. XYZ Devices recommended monitoring patients every 3-6 months for signs of abrasion failure. They did not recommend prophylactic removal of the leads.

A. Patient Information

3. Sex

4. Weight


B. Adverse Effects, Product Problem or Error

1. Check all that apply: (?HelpUseful TipThe HIPAA Privacy Rule specifically permits pharmacists, physicians, nurses, or hospitals (i.e. covered entities) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.)

C. Product Availability

Product Available for Evaluation? (Do not send product to FDA)

D. Suspect Product(s)

E. Suspect Device

5. Operator of Device

8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?

F. Other (Concomitant) Medical Products

G. Reporter

2. Health Professional?
4. Also Reported to: