BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC MAXIMO

    MDR report key: 2032971 · Received March 29, 2011

    Report

    Report Number
    6000144-2011-01096
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    August 23, 2005
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE REVEALED THE PATIENT IS DECEASED AND DIED APPROXIMTAELY EIGHT MONTHS POST SYSTEM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death