FDA Adverse Event Malfunction Summary report: N

COGNIS

MDR report key: 3050037 · Received April 10, 2013

Report

Report Number: 2124215-2013-03445
Event Type: Malfunction
Date Received: April 10, 2013
Date of Event: February 13, 2013
Report Date: February 20, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LONGEVITY TESTING WAS PERFORMED. ANALYSIS DETERMINED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT TRIGGER A REPLACEMENT INDICATOR WHILE IMPLANTED. REVIEW OF THE MEMORY LOG CONFIRMED THAT THERE WERE FAULTS RECORDED WHILE THIS CRT-D WAS IMPLANTED. THIS CRT-D MATCHED A TREND FOR DEVICES RETURNED WITH FAULT(S) DUE TO ELECTROCAUTERY/HIGH ENERGY. THE BEHAVIOR OF THIS DEVICE IS CONSISTENT WITH DEVICES THAT HAVE REVERTED TO SAFETY MODE DUE TO ELECTROCAUTERY. DESIGN CHANGES HAVE NOW BEEN IMPLEMENTED TO ENHANCE THE ROBUSTNESS OF ELECTRIC CIRCUITS, SUCH THAT A DEVICE WOULD BE ABLE TO WITHSTAND THE RARE OCCURRENCES OF CONDUCTED ENERGY THAT PREVIOUSLY WOULD HAVE DISRUPTED CIRCUIT PERFORMANCE.NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED FOR RELIABILITY ANALYSIS. INVESTIGATION INDICATED THAT IN (B)(6) OF LAST YEAR, THE DEVICE WAS EXPLANTED DUE TO INFECTION. (INFECTION REPORT WAS SUBMITTED, REPORT NUMBER 2124215-2012-15303). AVAILABLE INFORMATION INDICATES THERE WERE NO REPORTED COMPLICATIONS WHILE THE DEVICE WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
153190	COGNIS	IMPLANTABLE CHF PULSE GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	N119

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR			(B)(4)\| 4592\| N119\| 6947\| 4555