BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1992255 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-03029
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    October 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED 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 ALL CONDUCTORS DISTORTED, ALL CONDUCTORS ARE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), ALL INSULATORS WERE BREACHED CUT, 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 ALL CONDUCTORS DISTORTED, ALL CONDUCTORS ARE STRETCHED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FUNERAL HOME THAT THE PATIENT HAD EXPIRED 6 MONTHS AFTER UPGRADE TO A BI-VENTRICULAR PACEMAKER SYSTEM. CIRCUMSTANCES SURROUNDING THE DEATH HAVE BEEN REQUESTED AND NOT RECIEVED. NO COMPLAINTS OR ALLEGATIONS AGAINST THE DEVICE OR LEADS HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death| H| L| R