CAPSUREFIX NOVUS

Report

Report Number: 2649622-2012-16854
Event Type: Injury
Date Received: October 31, 2012
Date of Event: August 13, 2012
Report Date: November 8, 2012
Manufacturer: MPRI
Product Code: DTB
PMA / PMN Number: P930039/S017
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES FOUND. IT WAS NOTED THAT OUTER INSULATION HAD A BREACH CUT; BLOOD WAS PRESENT ON THE PROXIMAL LEAD CONDUCTOR AND DISTAL END OF LEAD ELECTRODES. VISUAL ANALYSIS INDICATED EXPLANT DAMAGE.

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH UNSTABLE THRESHOLDS. IT WAS ALSO NOTED THAT THERE WAS OVERSENSING AS THERE WAS A HIGH NUMBER OF VSE (VENTRICULAR SENSED EVENTS). THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH UNSTABLE THRESHOLDS. IT WAS ALSO NOTED THAT THERE WAS OVERSENSING AS THERE WAS A HIGH NUMBER OF VSE (VENTRICULAR SENSED EVENTS). 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
1	CAPSUREFIX NOVUS	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	4076

Patients

Seq	Age	Sex	Outcome	Treatment
1	00079 YR		Hospitalization\| R	4196 IMPLANTABLE TACHY LEAD\| 6935 IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB