FDA Adverse Event Injury Summary report: N

ENDOTAK ENDURANCE

MDR report key: 2780145 · Received October 10, 2012

Report

Report Number: 2124215-2012-12959
Event Type: Injury
Date Received: October 10, 2012
Date of Event: September 7, 2012
Report Date: September 7, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS RV LEAD REMAINS IN SERVICE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, SHORTLY AFTER IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH OUT OF RANGE (OOR) SHOCK IMPEDANCE MEASUREMENTS IN ALL THREE VECTORS. TECHNICAL SERVICES (TS) SUGGESTED PERFORMING AN X-RAY, AND A LOW SHOCK TEST TO ASSESS WHETHER THIS IS A CONNECTION ISSUE OR LEAD ISSUE. THIS PATIENT WILL BE FOLLOWED-UP WITHIN THE NEAR FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENTLY, THE PHYSICIAN DELIVERED A 1.1 JOULE SHOCK, AND IMPEDANCE MEASUREMENT WAS 46 OHMS. SHORTLY AFTER THE DELIVERED SHOCK, THE IMPEDANCE AGAIN INCREASED TO GREATER THAN 125 OHMS. TS REVIEWED AN X-RAY AND DISCUSSED THERE COULD POTENTIALLY BE UNDERINSERTION. TS REQUESTED A SAVE ALL TO DISK, A MEMORY DOWNLOAD, AND A BETTER X-RAY OR FLUOROSCOPY BE PERFORMED TO BETTER EVALUATE LEAD INSERTION INTO THE HEADER. AT THIS TIME, HOWEVER, NO FURTHER INTERVENTION IS PLANNED. THE PHYSICIAN ELECTED TO DISCHARGE THE PATIENT DUE TO NORMAL IMPEDANCE MEASUREMENTS AFTER THE LOW ENERGY 1.1 JOULE SHOCK. THE PATIENT DID NOT RECEIVE ANY THERAPY WITH HIS PREVIOUS DEVICE, SO THE PHYSICIAN DID NOT FEEL THIS WAS AN URGENT MATTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK ENDURANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0145

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening