FDA Adverse Event Injury Summary report: N

VITALITY 2

MDR report key: 1952017 · Received January 7, 2011

Report

Report Number: 2124215-2010-23236
Event Type: Injury
Date Received: January 7, 2011
Date of Event: December 2, 2010
Report Date: January 3, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Removal / Correction Number: Z-1620-09 TO Z-1621-09
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE INTERROGATION REVEALED THAT THE DEVICE BATTERY STATUS WAS ELECTIVE REPLACEMENT INDICATOR (ERI), WITH A BATTERY VOLTAGE OF 2.22 VOLTS. A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO TWO COMPROMISED LOW-VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION.

Additional Manufacturer Narrative · 1

THE ICD WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE DEVICE HAS BEEN RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER BEING IMPLANTED FOR 54 MONTHS. THERE WAS A CONCERN THAT THE BATTERY HAD DEPLETED EARLIER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

THE DEVICE WAS RETURNED.

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	80 YR		Required Intervention	T165