BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6900368 · Received September 28, 2017

    Report

    Report Number
    3007566237-2017-04100
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389S-40, LOT# V006947, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL. THE RIGHT INS WAS REPLACED ON THE DAY OF THIS REPORT AND THE SHORT CIRCUIT REMAINED ON THE 0-3 ELECTRODE CONFIGURATION. THE SHORT WAS NOT AFFECTING THE PATIENT'S THERAPY AND THEY WERE DOING WELL WITH DEEP BRAIN STIMULATION (DBS). NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED. REFER TO MANUFACTURER REPORT #3004209178-2015-05798 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682353 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1