FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS

MDR report key: 1792342 · Received August 11, 2010

Report

Report Number: 2649622-2010-07077
Event Type: Malfunction
Date Received: August 11, 2010
Date of Event: May 3, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S017
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND; THE ANALYST NOTED THAT THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION; FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED.

Description of Event or Problem · 1

IT WAS REPORTED THE LEADS WERE ATTEMPTED BUT NOT USED AS THE PHYSICIAN WAS UNABLE TO EXTEND THE HELIXES. A NEW LEAD 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			Required Intervention