FDA Adverse Event Malfunction Summary report: N

VITALITY

MDR report key: 1852042 · Received October 4, 2010

Report

Report Number: 2124215-2010-15324
Event Type: Malfunction
Date Received: October 4, 2010
Date of Event: July 7, 2010
Report Date: July 7, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
PMA / PMN Number: P960040
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE BOSTON SCIENTIFIC TECHNICAL SERVICES RECOMMENDED ATTEMPTING TO REPRODUCE NOISE IN CLINIC, AND OBTAINING A CHEST X-RAY FOR FURTHER ANALYSIS. THE POSSIBILITY OF REPROGRAMMING THE DEVICE TO MONITOR ONLY MODE UNTIL A REVISION PROCEDURE COULD BE PERFORMED WAS ALSO DISCUSSED. ADDITIONAL INFORMATION INDICATES THAT NO X-RAY WAS TAKEN, AND NO LEAD REVISION HAS BEEN SCHEDULED DUE TO THE PATIENT'S CONDITION. OF NOTE, THE PATIENT IS CURRENTLY UNDERGOING RADIATION THERAPY FOR CANCER. CURRENT RECORDS SUGGEST THAT THIS RV LEAD AND ICD REMAIN IN SERVICE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN RV PACING IMPEDANCE MEASUREMENT OF GREATER THAN 3000 OHM. LOSS OF CAPTURE IN THE RV WAS OCCURRING, AND THERE WAS SOME NOISE OBSERVED ON THE RV RATE/SENSE CHANNEL. THE PATIENT IS NOT PACEMAKER DEPENDENT, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THESE OBSERVATIONS.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Life Threatening	T180\| 0147\| 1853\| 4086