CAPSUREFIX NOVUS

MDR report key: 4831599 · Received June 10, 2015

Report

Report Number: 2649622-2015-05464
Event Type: Injury
Date Received: June 10, 2015
Date of Event: March 20, 2015
Report Date: March 20, 2015
Manufacturer: MPRI
Product Code: DTB
PMA / PMN Number: P930039
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 694765 LEAD, IMPLANTED: (B)(6) 2002; 5076-52 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. IT WAS ALSO NOTED THAT THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, THERE WAS DAMAGE AT EXPLANT, AND THAT THE LEAD WAS STRETCHED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR UNKNOWN REASONS. DURING ROUTINE INTERROGATION, OVERSENSING WAS OBSERVED ALONG WITH A HIGH IMPEDANCE AND INABILITY TO CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
377157	CAPSUREFIX NOVUS	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	5076-65

Patients

Seq	Age	Sex	Outcome	Treatment
1	00038 YR		Hospitalization\| R	7274 ICD