ENDOTAK RELIANCE

Report

Report Number: 2124215-2010-14235
Event Type: Injury
Date Received: October 4, 2010
Date of Event: July 12, 2010
Report Date: July 20, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
PMA / PMN Number: P910073
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

AN ATTEMPT HAS BEEN MADE TO GATHER ADDITIONAL INFORMATION ABOUT THIS EVENT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION INDICATES THAT THE INCREASE IN RV PACING THRESHOLDS DID LEAD TO SOME RV LOSS OF CAPTURE (LOC). SUBSEQUENTLY, A LEAD REVISION WAS PERFORMED, DURING WHICH THIS RV LEAD WAS SUCCESSFULLY REPOSITIONED WITHOUT ANY ADVERSE PATIENT EFFECTS RESULTING. THE POSSIBILITY OF AN RV LEAD MICRODISLODGEMENT OR A CHANGE IN PATIENT CONDITION WAS DISCUSSED. AVAILABLE INFORMATION SUGGESTS THAT THIS RV LEAD REMAINS IN SERVICE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RECENTLY IMPLANTED TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING INCREASED PACING THRESHOLDS OF 4.5 V, AND A DROP IN R-WAVE SENSING FROM 25 MV TO 9 MV. LEAD IMPEDANCE MEASUREMENTS REMAIN WITHIN NORMAL RANGE. THE POSSIBILITY OF AN RV LEAD DISLODGEMENT WAS DISCUSSED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THESE OBSERVATIONS. A REVISION PROCEDURE IS PLANNED, AND AVAILABLE INFORMATION SUGGESTS THAT THE PHYSICIAN WILL TRY TO REPOSITION THIS RV LEAD.

Description of Event or Problem · 1

--

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0181

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Life Threatening	E102\| 0181