BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4250979 · Received November 14, 2014

    Report

    Report Number
    3007566237-2014-03334
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 3765,1 LOT# SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DYSTONIA PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN DEPLETED FOR 24 HOURS AT THE TIME OF REPORT BECAUSE THE PATIENT ¿COULD NOT GET ANY COUPLING¿ BETWEEN THEIR RECHARGER AND INS AND ¿THUS COULD NOT CHARGE.¿ THE PATIENT EXPERIENCED A ¿RETURN OF DYSTONIC SYMPTOMS¿ DUE TO A ¿LOSS OF STIMULATION¿ AS A RESULT OF THE DEPLETED INS. THE RECHARGER WAS REPLACED AS A RESULT OF THE EVENT. THE PATIENT ¿WAS ABLE TO RECHARGE WITH THE NEW CHARGER;¿ HOWEVER, THEY ¿STILL HAD NO SYMPTOM CONTROL.¿ THE MANUFACTURER REPRESENTATIVE INVOLVED IN THE CASE ¿SUSPECTED THE DEVICE WAS SWITCHED OFF,¿ BUT HAD BEEN UNABLE TO CONFIRM THIS AS OF TWO WEEKS AFTER INITIAL REPORT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP). ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CONFIRMED ¿THE DEVICE WAS SWITCHED OFF¿ AND ¿THAT¿S WHY THE SYMPTOMS HAD RETURNED.¿ THE PATIENT¿S INS WAS ¿SWITCHED BACK ON¿ AND THE ¿SYMPTOMS WERE ALLEVIATED¿ AT THAT TIME. THE PATIENT WAS NOTABLY GIVEN A PATIENT PROGRAMMER AND TAUGHT HOW TO SWITCH THE INS BACK ON HERSELF, IN CASE THE EVENT WAS TO HAPPEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738352 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1