FDA Adverse Event Injury Summary report: N

ALTRUA

MDR report key: 1951492 · Received January 6, 2011

Report

Report Number: 2124215-2010-23129
Event Type: Injury
Date Received: January 6, 2011
Date of Event: November 24, 2010
Report Date: January 12, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
PMA / PMN Number: D970003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

VISUAL INSPECTION OF THIS DEVICE CONFIRMED ALL SEAL PLUGS WERE INTACT. THE DISTAL SETSCREW WAS STUCK IN THE UP POSITION. A REAL TIME X-RAY WAS PERFORMED ON THE DEVICE WHICH CONFIRMED THAT THE DISTAL SETSCREW WAS SLIGHTLY ANGLED IN THE CONNECTOR BLOCK, CONFIRMING THE SETSCREW WAS CROSS THREADED IN THE CONNECTOR BLOCK. IN ADDITION, AN IS-1 LEAD WAS TESTED ON THE DEVICE AND IT WAS NOTED THAT THE LEAD COULD BE FULLY INSERTED INTO THE LEAD BARREL FREELY. THE PACING AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED PER AUTOMATED TESTING WHICH CONFIRMED PROPER DEVICE OPERATION. A REVIEW OF THE DEVICE'S MEMORY REVEALED BENIGN RATE FAULT RESETS, A BEHAVIOR AND DOES NOT HAVE ANY IMPACT ON THE PATIENT THERAPY. LABORATORY ANALYSIS CONFIRMED THE ALLEGATION IN THE FIELD WAS THE RESULT OF CROSS THREADING SETSCREWS WHICH CAUSED AN INCOMPLETE CONNECTION OF THE LEAD.

Additional Manufacturer Narrative · 1

UPON ANALYSIS THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NO PACING WAS NOTED WHEN THIS PULSE GENERATOR (PG) WAS CONNECTED TO THE LEAD. THERE WERE NO ALLEGATIONS AGAINST THE LEAD, WHILE THE DEVICE WAS NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PG WAS EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S201

Patients

Seq	Age	Sex	Outcome	Treatment
1			Congenital Anomaly