BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2082925 · Received May 10, 2011

    Report

    Report Number
    2649622-2011-07458
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    February 9, 2011
    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
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION HOWEVER WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. REVIEW OF THE DATA SHOWED THAT NO ANOMALIES FOUND. ADDITIONAL INFORMATION OBTAINED INCLUDED THE FOLLOWING; A COMPETITOR REP INTERROGATED THE DEVICE FIRST BEFORE EXPLANT. WHEN THE DEVICE AND LEAD WERE REMOVED FROM THE PATIENT THERE WAS A LOT OF DAMAGE TO IT, IT WAS NOT SHUT OFF AND IT SHOCKED AND SHOCKED AND DRAINED THE BATTERY. THE MANUFACTURE'S REP WAS CALLED IN AND INTERROGATED IT POST EXPLANT AND SAID THE RESULTS WOULD NOT BE TOTALLY ACCURATE BECAUSE OF THE EXPLANT DAMAGE; HOWEVER THE READINGS BUT LEADING UP TO THE DAY OF DEATH HAD NORMAL MEASUREMENTS. THE FAMILY WAS GIVEN THE DEVICE. IN ADDITION THE FAMILY IS PART OF A LAWSUIT REGARDING A DEFIBRILLATION LEAD THE PATIENT HAD EXPLANTED ON (B)(6) 2008. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED INCLUDED THE FOLLOWING; A COMPETITOR REP INTERROGATED THE DEVICE FIRST BEFORE EXPLANT. WHEN THE DEVICE AND LEAD WERE REMOVED FROM THE PATIENT THERE WAS A LOT OF DAMAGE TO IT, IT WAS NOT SHUT OFF AND IT SHOCKED AND SHOCKED AND DRAINED THE BATTERY. THE MANUFACTURE'S REP WAS CALLED IN AND INTERROGATED IT POST EXPLANT AND SAID THE RESULTS WOULD NOT BE TOTALLY ACCURATE BECAUSE OF THE EXPLANT DAMAGE; HOWEVER THE READINGS BUT LEADING UP TO THE DAY OF DEATH HAD NORMAL MEASUREMENTS. THE FAMILY WAS GIVEN THE DEVICE. IN ADDITION, THE FAMILY IS PART OF A LAWSUIT REGARDING A DEFIBRILLATION LEAD THE PATIENT HAD EXPLANTED ON (B)(6) 2008. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE DEVICE AND LEAD WERE AT FAULT FOR THE PATIENT'S DEATH. 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 75 YR Death