BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3790281 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08510
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # VA0AWNQ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT EXPERIENCED THE SHOCKING SENSATION ON (B)(6) 2014. THE PATIENT TURNED THEMSELVES ON AND GOT SHOCKED. IT WAS NOTED THAT IT WAS BECAUSE THE PATIENT WAS SET UP AT 3.6V. PATIENT FELT THE SHOCK AT THE BATTERY SITE. THE NURSE STATED ¿THE PROBLEM WAS BIGGER THAN JUST TURNING IT ON AND GETTING A SHOCK FROM BEING AT 3.6V.¿ THE PATIENT FELT THE SHOCK RIGHT IN THE CHEST WHERE THE DEVICE WAS. IT WAS NOTED THAT THE SHOCKING SENSATION HAD LASTED ABOUT 20-30 SECONDS. THE PATIENT WAS INSTRUCTED TO TURN THERAPY OFF AND TURN STIMULATION DOWN TO 0.0V AND THEN TO TURN THERAPY BACK ON AND INCREASE STIMULATION. THERAPY WAS TURNED OFF AND AT 3.6V. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON THE LEFT SIDE TO CONTROL THE RIGHT SIDE OF THE BODY. STIMULATION WAS SUCCESSFULLY TURNED DOWN TO 0.0V AND THEN TURNED ON AND INCREASED TO 3.5V. THE PATIENT HAD NOT FELT A SHOCK. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267790 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR