BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3781527 · Received April 30, 2014

    Report

    Report Number
    3007566237-2014-01191
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMTIANT PRODUCT: PRODUCT ID 3389S-40, LOT# VA07VDXV02, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE HIGH IMPEDANCE READINGS. IT WAS NOTED THE IMPEDANCE VALUE WAS 11,849 OHMS ON ELECTRODE 11. IT WAS NOTED THERE WAS DAMAGE DETECTED CAPPING THE LEAD. IT WAS STATED THE SURGEON HAD DECIDED TO KEEP THE LEAD IN PLACE AND NOT USE THE 11 CONTACT DURING PROGRAMMING. IT WAS NOTED THE LEAD MAY HAVE BEEN DAMAGED DURING IMPLANTATION, SPECIFICALLY WHEN THE LEAD END CAP WAS PUT ON. IT WAS STATED THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THERE WERE NO PATIENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259668 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR