CAPSUREFIX NOVUS

Report

Report Number: 2649622-2010-12063
Event Type: Death
Date Received: November 10, 2010
Date of Event: May 5, 2008
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Removal / Correction Number: ASKU
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
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.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2008 AND THAT IT WAS DEVICE RELATED. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC TAMPONADE SECONDARY TO ATRIAL LEAD PERFORATION. FOLLOW UP WITH PHYSICIAN REVEALED INDICATION FOR DEVICE PLACEMENT HAD BEEN TACHYBRADY SICK SINUS SYNDROME. IMPLANT REPORTED TO HAVE GONE WITHOUT COMPLICATION AND DEVICE CHECK NEXT DAY WAS SATISFACTORY. PATIENT HAD MORE ATRIAL FIBRILLATION AND MEDICATION WAS INCREASED. PATIENT WAS DISCHARGED SEVEN DAYS PRIOR TO DEATH. PHYSICIAN REPORTED "THAT THE PRESENCE OF LEFT VENTRICULAR DYSFUNCTION FROM A CARDIOMYOPATHY WOULD PREDISPOSE (PATIENT) TO AN INCREASED RISK OF SUDDEN DEATH THAT WOULD NOT HAVE BEEN PREVENTED BY THE PACEMAKER AND MAY NOT HAVE BEEN PREVENTED BY THE ONGOING ANTIARRHYTHMIC THERAPY."

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2008 AND THAT IT WAS DEVICE RELATED. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC TAMPONADE SECONDARY TO ATRIAL LEAD PERFORATION. ADDITIONAL INFORMATION 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	89 YR		Death