BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1971200 · Received January 26, 2011

    Report

    Report Number
    2649622-2011-00118
    Event Type
    Death
    Date Received
    January 26, 2011
    Date of Event
    December 2, 2010
    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
    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): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. EVALUATION SUMMARY: (B)(4):THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DEFIBRILLATION CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS CUT, ALL THE CONDUCTORS WERE STRETCHED, THERE WAS A DISTAL CONDUCTOR FRACTURE DUE TO OVERSTRESS, ALL THE INSULATION'S WERE TORN AND THE OUTER INSULATION HAD COSMETIC DEPRESSION. IN ADDITION THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS CUT AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE AND LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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

    PER THE MANUFACTURE DATA BASE THE PATIENT DIED APPROXIMATELY FOUR MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR. THROUGH INVESTIGATION IT WAS REPORTED THAT THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION, SECONDARY TO CARDIOMYOPATHY. MORE INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    PER THE MANUFACTURE DATA BASE THE PATIENT DIED APPROXIMATELY FOUR MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR. THROUGH INVESTIGATION IT WAS REPORTED THAT THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION, SECONDARY TO CARDIOMYOPATHY. MORE 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 86 YR Death