FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 1945831 · Received January 4, 2011

Report

Report Number: 2124215-2010-21356
Event Type: Injury
Date Received: January 4, 2011
Date of Event: October 13, 2010
Report Date: October 13, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE PACEMAKER REMAINS IN SERVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED SINCE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THIS PACEMAKER REPLACEMENT PROCEDURE AFTER THE NEW DEVICE WAS IMPLANTED, THE PHYSICIAN CLOSED THE POCKET AND NOTED ATRIAL LEAD IMPEDANCES GREATER THAN 2,500 OHMS. THE POCKET WAS REOPENED AND IT WAS OBSERVED THE THE ATRIAL LEAD WAS NOT INSERTED ALL THE WAY INTO THE HEADER. THE VENTRICULAR LEAD WAS ALSO CHECKED AND WAS FOUND TO NOT BE COMPLETELY INSERTED INTO THE HEADER, HOWEVER IT WAS FAR ENOUGH THAT MEASUREMENTS WERE NORMAL. THE PHYSICIAN RESEATED BOTH LEADS SECURELY AND RECONNECTED THE SETSCREWS. THIS RESOLVED THE ISSUE. IT WAS NOTED THAT THE ISSUE WAS LIKELY DUE TO THE TIGHTENING OF THE SETSCREWS NOT ALLOWING THE LEADS TO BE COMPLETELY INSERTED INTO THE HEADER. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED DURING THIS PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S603

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Required Intervention	1273\| 4450\| 1284\| S603\| 4460