FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS

MDR report key: 2790667 · Received October 15, 2012

Report

Report Number: 2649622-2012-14160
Event Type: Malfunction
Date Received: October 15, 2012
Date of Event: July 30, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY : (B)(4) : THE FULL LEAD WAS RETURNED AND ANALYZED; ANALYSIS REVEALED THE DISTAL CONDUCTOR WAS DISTORTED. THE PROXIMAL CONDUCTOR WAS ALSO DISTORTED, STRETCHED, AND THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON IT. THERE WAS AN OVERSTRESS FRACTURE OF THE DISTAL CONDUCTOR, THE INNER INSULATION AND TUBING WAS KINKED/BUCKLED, AND THE OUTER INSULATION HAD A BREACHED CUT AND COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX MECHANISM, TISSUE ON THE HELIX, THE LEAD WAS STRETCHED, AND THERE WAS A DEFORMATION/FRACTURE IN THE PROXIMAL SECTION OF THE INNER COIL. VISUAL ANALYSIS NOTED THAT, WHILE THE STYLET WAS NOT RETURNED WITH THE LEAD, ANOTHER STYLET WAS USED FOR THE TESTING AND IT FAILED DUE TO THE DISTAL CONDUCTOR DISTORTION/FRACTURE WITHIN THE CONNECTOR.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PHYSICIAN WENT IN FOR A LEAD REPOSITION TO REMOVE SLACK IN THE LEAD. AFTER PULLING BACK THE LEAD WITH STYLET IN PLACE, A NEW STYLET WOULD NOT GO DOWN THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO COMPLICATIONS WERE NOTED 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	52 YR		Other	5076 IMPLANTABLE PACING LEAD\| ADDR01 IMPLANTABLE PULSE GENERATOR