FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS

MDR report key: 2781704 · Received October 11, 2012

Report

Report Number: 2649622-2012-12898
Event Type: Malfunction
Date Received: October 11, 2012
Date of Event: June 4, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT IS REPORTED BASED ON ANALYSIS. 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS NOTED TO HAVE A BLOOD/FLUID OBSTRUCTION, AND BLOOD/BODY FLUID WAS FOUND ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE BLOOD IN THE DISTAL CONDUCTOR LIKELY ENTERED THROUGH THE IS-1 PIN AS NO INSULATION BREACH WAS OBSERVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE GUIDE WIRE COULD NOT BE INSERTED INTO THE LEAD. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	5076

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other