FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 2910791 · Received January 11, 2013

Report

Report Number: 2124215-2012-16697
Event Type: Injury
Date Received: January 11, 2013
Date of Event: November 9, 2012
Report Date: November 9, 2012
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: PHYSICIAN

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.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF CROSS TALK FROM THE ATRIAL CHANNEL WITH GREATER THAN FIVE SECONDS OF PACING INHIBITION. A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED AND THE SENSITIVITY WAS ADJUSTED AND OTHER ZONE PROGRAMMING CHANGES WERE MADE. IT WAS NOTED THAT THE PATIENT WAS ASYMPTOMATIC DUE TO THE PACING INHIBITION. THERE HAVE BEEN NO ADDITIONAL OVERSENSING EPISODES NOTED SINCE THE PROGRAMMING CHANGE. WHEN MAKING THE PROGRAMMING CHANGES IT WAS OBSERVED THAT THE MAGNET RESPONSE WAS UPDATED, HOWEVER, THE FIELD REPRESENTATIVE STATED THAT SHE DID NOT REPROGRAM THE MAGNET RESPONSE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND ENGINEERING WERE CONSULTED. IT WAS DETERMINED THAT SOME SETTINGS ARE CHANGED INDIRECTLY BASED UPON OTHER CHANGES MADE TO THE DEVICE. THIS WAS NORMAL DEVICE FUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17089	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0185

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Life Threatening\| R	253-05\| N119\| MISMATCH\| 4554\| 4136\| 0185