FDA Adverse Event Malfunction Summary report: N

ALTRUA

MDR report key: 1953661 · Received January 10, 2011

Report

Report Number: 2124215-2010-23843
Event Type: Malfunction
Date Received: January 10, 2011
Date of Event: December 10, 2010
Report Date: December 17, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
PMA / PMN Number: D970003/S106
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AT THIS TIME THE DEVICE REMAINS IMPLANTED AND THUS WILL NOT BE RETURNED FOR ANALYSIS. SHOULD ADDDITIONAL INFORMATION BECOME AVAILABLE THIS PI WILL BE UPDATED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS PROVIDED BY TECHNICAL SERVICES. TECHNICAL SERVICES CONFIRMED INCREASE IMPEDANCES AS WELL AS LOSS OF CAPTURE WITH BIPOLAR SIMULATION WHILE UNIPOLAR SHOWS NORMAL IMPEDANCES AND NORMAL CAPTURE. A POSSIBLE FRACTURE OF THE RV LEAD WAS DISCUSSED AS WELL AS A POSSIBLE CONNECTION ISSUE. A LEAD REVISION WAS ADVISED, HOWEVER IT WAS NOTED THAT THE FINAL DECISION SHOULD BE LEFT TO THE DESCRETION OF THE PHYSICIAN. AT THIS TIME THE DEVICE AND LEAD REMAINS IMPLANTED AND THUS WILL NOT BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS PI WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A FOLLOW UP INCREASED RIGHT VENTRICULAR PACING THRESHOLDS OUT OF RANGE PACING IMPEDANCES AND PACING FAILURE WAS NOTED. NO LEAD FRACTURE WAS OBSERVED. THE PULSE GENERATOR (PG) WAS REPROGRAMMED FROM BIPOLAR CONFIGURATION TO UNIPOLAR CONFIGURATION AND A FOLLOW UP WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA		NVZ	GUIDANT CRM CLONMEL IRELAND	S606

Patients

Seq	Age	Sex	Outcome	Treatment
1