ENDOTAK DSP

MDR report key: 1951478 · Received January 6, 2011

Report

Report Number: 2124215-2010-23084
Event Type: Malfunction
Date Received: January 6, 2011
Date of Event: November 23, 2010
Report Date: December 10, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR (B)(4) LABORATORY, THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. THE LEAD WAS RETURNED SEVERED 28.5 CENTIMERS (CM) FROM THE TERMINAL PIN; THE PROXIMAL SECTION ONLY WAS RETURNED. SETSCREW MARKS WERE NOTED ON ALL TERMINALS INDICATING THE LEAD WAS PROPERLY SEATED IN THE HEADER OF THE CHRONIC DEVICE. A SEPARATION BETWEEN THE TERMINAL END INSULATION AND THE ANODE RING WAS MEASURED. THIS DAMAGE IS CONSISTENT WITH A COMPROMISED MEDICAL ADHESIVE BOND BETWEEN THE INSULATION AND THE ANODE RING.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE REPLACEMENT PROCEDURE, WHEN THIS TRANSVENOUS DEFIBRILLATION LEAD WAS DISCONNECTED FROM THE OLD DEVICE, THE PORTION OF THE LEAD BETWEEN THE PROXIMAL AND DISTAL CONNECTORS WAS NOTED TO HAVE COME APART. THE PHYSICIAN CUT AND SURGICALLY CAPPED THE LEAD, AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION. THE LEAD WAS RETURNED FOR ANALYSIS.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK DSP	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0125

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR			E102\| 0125\| 0185\| 1860\| 1782