BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1013521 · Received March 10, 2008

    Report

    Report Number
    2647346-2008-00086
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    March 23, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NKE
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NKE MEDTRONIC MED REL, INC. 7297 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R SP01 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 1488TC IMPLANTABLE PACING LEAD