FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS

MDR report key: 1862842 · Received October 9, 2010

Report

Report Number: 2649622-2010-10530
Event Type: Malfunction
Date Received: October 9, 2010
Date of Event: July 19, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S017
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Location: OH, 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) NO ANOMALIES FOUND; FULL LEAD ANALYZED. THE HELIX WAS FOUND DISTORTED/BENT AND BLOOD PRESENT IN/ON THE HELIX MECHANISM; LEAD DAMAGED AT IMPLANT. (B)(4) NO ANOMALIES FOUND; FULL LEAD ANALYZED. BLOOD PRESENT IN/ON THE HELIX MECHANISM.

Description of Event or Problem · 1

IT WAS REPORTED THAT A FIRST LEAD COULD NOT BE SEATED IN THE WALL OF THE RIGHT ATRIUM. AFTER TRYING SEVERAL TIMES, THE LEAD HELIX APPEARED TO BE "GUMMED UP WITH TISSUE" AND WOULDN'T EXTEND AND RETRACT VERY WELL. THE LEAD WAS REMOVED AND REPLACED WITH A SECOND LEAD WITH THE SAME RESULTS. A THIRD LEAD OF A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE 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.	4076	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention