FDA Adverse Event Death Summary report: N

CAPSUREFIX NOVUS

MDR report key: 1820537 · Received August 31, 2010

Report

Report Number: 2649622-2010-08947
Event Type: Death
Date Received: August 31, 2010
Date of Event: April 8, 2009
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH), DISTAL CONDUCTOR DISTORTED, BLOOD IN/ON HELIX/LOBE MECHANISM, LEAD STRETCHED. FULL LEAD RETURNED AND ANALYZED.

Description of Event or Problem · 1

THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP REVEALED THE PATIENT WAS LAST SEEN IN THE CLINIC (B)(6)2002 AND THE LAST PHONE CHECK OF DEVICE WAS (B)(6)2009. THE PHYSICIAN REPORTED THE LEADS AND DEVICE WERE NOT INVOLVED IN THE PATIENT DEATH AND THE CAUSE OF DEATH WAS COMPLICATIONS OF BOWEL INFARCTION.

Description of Event or Problem · 1

THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPSUREFIX NOVUS	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	5076	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death	KSR901 IMPLANTABLE PULSE GENERATOR