BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5391570 · Received January 26, 2016

    Report

    Report Number
    6000153-2016-00231
    Event Type
    Injury
    Date Received
    January 26, 2016
    Report Date
    January 5, 2016
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V971421, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THEIR COMPLETE SYSTEM WAS REMOVED DUE TO WIRES BREAKING OFF. THE CAUSE OF THE WIRES BREAKING WAS UNKNOWN. THERE WERE NO FALLS OR TRAUMA. THE PATIENT DID HAVE AN INFECTION IN THEIR HEAD AND THEY WERE ON ANTIBIOTICS FOR THAT. THE PATIENT ALSO HAD A NEEDLE "SHOVED" INTO THEIR RIGHT ARM MUSCLE. IF THE PATIENT HAD KNOWN THEY WERE DIABETIC, THEY MAY NOT HAVE GOTTEN THE IMPLANT. NO CAUSE, TROUBLESHOOTING OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #6000153-2016-00228, 6000153-2016-00229, AND 6000153-2016-00230.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48759 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 V971421

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention