FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 2040117 · Received April 5, 2011

Report

Report Number: 2124215-2011-00477
Event Type: Injury
Date Received: April 5, 2011
Date of Event: January 4, 2011
Report Date: January 4, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS SUCCESSFULLY REPOSITIONED AND SECURELY SUTURED DOWN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD EXPERIENCED A SYNCOPAL EPISODE AND WAS BROUGHT TO THE EMERGENCY ROOM. SYSTEM EVALUATION NOTED ERRATIC AND INCONSISTENT PACING SPIKES. THE ASSOCIATED RIGHT VENTRICULAR DEXTRUS LEAD WAS EXHIBITING CAPTURE IN THE ATRIUM AND THE DEXTRUS ATRIAL LEAD WAS EXHIBITING NO CAPTURE. A REVIEW OF AN X-RAY FROM ONE DAY POST IMPLANT REVEALED THE ATRIAL LEAD HAD ALREADY APPEARED TO BE DISLODGED. TODAY'S X-RAY SHOWED THE RIGHT VENTRICULAR LEAD WAS ALSO DISLODGED. TWIDDLERS SYNDROME IS SUSPECTED AS THIS DEVICE APPEARS TO HAVE BEEN TURNED AROUND FROM THE INITIAL POST IMPLANT X-RAY. THIS PATIENT IS NOT PACEMAKER DEPENDENT AND HAS AN INTRINSIC RATE BETWEEN 75-95 BPM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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	56 YR			4136\| 4135\| S606