FDA Adverse Event Injury Summary report: N

VITALITY

MDR report key: 3771466 · Received April 24, 2014

Report

Report Number: 2124215-2014-09179
Event Type: Injury
Date Received: April 24, 2014
Date of Event: October 25, 2013
Report Date: February 27, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. EOL WAS DECLARED WITHOUT ERI. THE DEVICE AND BATTERY BEHAVIOR MATCH THAT OF TRENDED UNITS THAT REACH ERI/EOL PREMATURELY DUE TO A HIGHER THAN EXPECTED CELL IMPEDANCE INCREASE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT TRIGGER ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS CHECKED FIVE MONTHS AGO AND THE CHARGE TIME (CT) WAS 25 SECONDS BUT ON THE DAY OF CHECK, IT WAS 35 SECONDS. AFTER THAT CHECK, THE CT WENT ABOVE 26.1 SECONDS. THIS ICD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
248959	VITALITY	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T180

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Hospitalization\| L	T180\| 0185