BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 784875 · Received November 10, 2006

    Report

    Report Number
    6000144-2006-00196
    Event Type
    Injury
    Date Received
    November 10, 2006
    Date of Event
    September 5, 2006
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES, WHEN MEASURED THROUGH THE DEVICE, FOR THE HVB AND SCV COILS WERE HIGH AT GREATER THAN 200 OHMS. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other