VITALITY 2

MDR report key: 1873861 · Received October 19, 2010

Report

Report Number: 2124215-2010-17628
Event Type: Malfunction
Date Received: October 19, 2010
Date of Event: September 3, 2010
Report Date: September 30, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Removal / Correction Number: Z-1047-2007 TO Z-1055-20
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

Additional Manufacturer Narrative · 1

A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND WAS RETURNED FOR DISPOSAL. ROUTINE INITIAL DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T165

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR			0185\| 1861\| T165\| 6949\| 0158\| (B)(4)\| E110\| MISMATCH