BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7226618 · Received January 29, 2018

    Report

    Report Number
    3004209178-2018-01614
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    November 1, 2017
    Report Date
    March 7, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994934611
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS AN APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: TO INCLUDE P960009. OMITTING THE FOLLOWING INFORMATION FROM [REFER TO PE 701642617 FOR INFORMATION RELATED TO THE PATIENT'S DEVICE NOT CHARGING PAST 50%, LEAD MALFUNCTIONING, DEVICE MALFUNCTIONING.] IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S RECHARGER IS NOT WORKING AND NEEDS A NEW ONE. THE PATIENT STATES THEY KEEP GETTING THE REPOSITION ANTENNA SCREEN ON RECHARGER AND IT WON'T CHARGE PAST 50% AND THE LAST TIME THEY USED CHARGER WAS TWO MONTHS AGO. THE PATIENT IS NOT GETTING A CONNECTION ON REMOTE OR RECHARGER. THE PATIENT ALSO WENT TO THE DOCTOR YESTERDAY AND THE DOCTOR COULD NOT GET SETTINGS YESTERDAY. IT WAS ADVISED TO THE PATIENT THAT THEIR BATTERY IS IN AN OVERDISCHARGE STATE AND TO CALL THE DOCTOR TO GET THEIR BATTERY RESTORED. REFER TO (B)(4) FOR INFORMATION RELATED TO THE PATIENT'S DEVICE NOT CHARGING PAST 50%, LEAD MALFUNCTIONING, DEVICE MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69952 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00613994934611

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR