FDA Adverse Event Malfunction Summary report: N

ENDOTAK RELIANCE

MDR report key: 3210382 · Received July 8, 2013

Report

Report Number: 2124215-2013-08225
Event Type: Malfunction
Date Received: July 8, 2013
Date of Event: April 17, 2013
Report Date: April 17, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

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 THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT A LOW, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS DETECTED. DEVICE EVALUATION WAS DONE, AND THE FIELD REPRESENTATIVE WAS UNABLE TO REPRODUCE ANY ISSUES AND THE CHECK WAS NORMAL. THE PATIENT NOTED THAT ON THE DAY THE OOR IMPEDANCE WAS DETECTED, SHE HAD ELECTRICAL STIMULATION THERAPY ON HER LEFT SHOULDER OVER A TEN MINUTE PERIOD; THIS WAS BEING PERFORMED DUE TO SHOULDER PAIN. THE FIELD REPRESENTATIVE DISCUSSED WITH THE PHYSICIAN THE POTENTIAL THAT THE OOR MEASUREMENT WAS CAUSED BY ELECTROMAGNETIC INTERFERENCE (EMI) DUE TO THE ELECTRICAL STIMULATION OR THAT IT COULD BE THE START OF A LEAD ISSUE. AT THIS TIME THE PHYSICIAN ELECTED CONTINUED MONITORING WITH THE HOME REMOTE SYSTEM, AND THE PATIENT WAS TO DOCUMENT THE DATES SHE HAS ELECTRICAL STIMULATION THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
309802	ENDOTAK RELIANCE	IMPLANTABLE LEAD	NVY	CPI - DEL CARIBE	0157

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR			4542\| 0157\| 4470\| N119