ENDOTAK RELIANCE

Report

Report Number: 2124215-2013-06303
Event Type: Injury
Date Received: April 16, 2013
Date of Event: March 22, 2013
Report Date: May 10, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED, AND THERE WERE SETSCREW MARKS NOTED ON THE TERMINAL PIN. THE MEDICAL ADHESIVE WAS TORN AT THE PROXIMAL END OF THE SPRING ELECTRODE AND THE PROXIMAL SPRING WAS STRETCHED. ADDITIONALLY THERE WAS A CUT FOUND IN THE INSULATION AND THE INSULATION SLEEVE WAS BUNCHED UP IN SEVERAL PLACES ALONG WITH THE POLY INSULATION SLEEVE. THERE WAS BODILY FLUID FOUND IN THE HELIX HOUSING AND TISSUE ENTWINED IN THE LEAD HELIX, WHICH WAS RETURNED RETRACTED. THE LEAD TIP AND HELIX APPEAR INTACT AND UNDAMAGED. IN CONCLUSION THE LEAD TIP AND HELIX HAD NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH WOULD HAVE LEAD TO DISLODGEMENT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED INCREASED IMPEDANCES FROM 510 OHMS UP TO 1800 OHMS. A CHEST X-RAY WAS TAKEN AND SHOWED THAT THIS LEAD HAD DISLODGED. AS A RESULT, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

Description of Event or Problem · 1

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Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
163444	ENDOTAK RELIANCE		NVY	CPI - DEL CARIBE	0295

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Hospitalization\| L\| R	0295\| E140