VITALITY 2

MDR report key: 2781119 · Received October 10, 2012

Report

Report Number: 2124215-2012-13253
Event Type: Injury
Date Received: October 10, 2012
Date of Event: September 20, 2012
Report Date: October 16, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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 RECEIVED INFORMATION THAT THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO INCREASED CHARGE TIMES. THE PHYSICIAN HAS ELECTED TO EXPLANT THE DEVICE AS A RESULT. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T167

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Hospitalization\| L\| R	4470\| 0185\| T167