BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3231157 · Received July 17, 2013

    Report

    Report Number
    3007566237-2013-02371
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 14, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-1190-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INS (IMPLANTABLE NEUROSTIMULATOR) CHANGEOUT, WHEN THE INS WAS UNHOOKED INS, #3 ELECTRODE LOOKED "MANGLED." IMPEDANCE CHECK SHOWED SOME HIGHER VALUES. CONTACTS C-0 HAD 2,016 OHMS, C-1=2,041 OHMS, C-2>40,000 OHMS, C-3=11,271 OHMS, 0-2>40,000 OHMS, 0-3=13,608 OHMS; 1-2>40,000 OHMS, 1-3 = 13,377 OHMS, 2-3>40,000 OHMS. IT WAS STATED THAT THE PATIENT WAS GETTING SYMPTOM RELIEF WITH ELECTRODES 0 AND 1 PROGRAMMED. IT WAS STATED THAT ONLY INS HAD BEEN CHANGED OUT AND IT WAS POSSIBLE TO RECONNECT COMPONENTS WITHOUT ISSUES. ALMOST TWO WEEKS LATER IT WAS REPORTED THAT PREVIOUSLY PROVIDED INFORMATION WAS NOT CORRECT. THE PROCEDURE DID NOT INVOLVE A BATTERY CHANGE, BUT IT WAS ACTUALLY A STAGE 2 DBS IMPLANT PROCEDURE. IT WAS STATED THAT WHEN THE SURGEON REMOVED THE LEAD END CAP, HE NOTICED THAT BOTH CONTACTS 2 AND 3 WERE DAMAGED WITH HIGH IMPEDANCES. THE STAGE 2 WAS COMPLETED, AS CONTACTS 0 AND 1 WERE STILL INTACT, AND THE PATIENT RECEIVED GOOD THERAPY FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331198 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1