FDA Adverse Event Injury Summary report: N

FORTIFY DR, DF-4 CONNECTOR

MDR report key: 3914550 · Received July 3, 2014

Report

Report Number: 2938836-2014-13072
Event Type: Injury
Date Received: July 3, 2014
Date of Event: April 7, 2014
Manufacturer: ST. JUDE MEDICAL, INC., CRMD
Product Code: LWS
PMA / PMN Number: P910023
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED FIELD EVENT OF AN INABILITY TO COMMUNICATE WITH THE DEVICE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO PREMATURE BATTERY DEPLETION. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY. NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND ANALYSIS COULD NOT CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE PREMATURE BATTERY DEPLETION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP. THE PHYSICIAN ATTEMPTED TO INTERROGATE THE ICD WITH TWO PROGRAMMERS. A TELEMETRY TEST WAS UNSUCCESSFUL. REPLACEMENT OF THE ICD WAS RECOMMENDED. TWO WEEKS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO SEVERE SHORTNESS OF BREATH. THE ICD WAS NOT PACING AND THE PATIENT HAD EMERGENCY DEVICE REPLACEMENT. THE PHYSICIAN NOTED THE ICD WAS AT PREMATURE ERI. THE PATIENT WAS STABLE AFTER THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389674	FORTIFY DR, DF-4 CONNECTOR	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	ST. JUDE MEDICAL, INC., CRMD	CD2231-40Q	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Required Intervention