BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2896948 · Received January 4, 2013

    Report

    Report Number
    3007566237-2013-00035
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 3387S-40, LOT#: V947057, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A LEAD WAS BENT BETWEEN CONTACT 0 AND 1. THE LEAD WAS NOT IMPLANTED. ANOTHER LEAD WAS USED AND ALL IMPEDANCES WERE NORMAL. IT WAS NOTED THAT THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4602 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1