BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2022147 · Received February 28, 2011

    Report

    Report Number
    3004209178-2011-01489
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT FELL DOWN AND HIT HER HEAD SUFFERING A LOSS OF STIMULATION. THE DBS IS SHUT OFF AND NOT WORKING AT ALL. PT IS SCHEDULED FOR A REVISION NEXT WEEK TO FIX THE DBS. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT. REFER TO MF REPORT # 3004209178201101490 FOR INFO ON THE SECOND INS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ105321N| IMPLANTABLE NEURO STIMULATOR: MODEL 37601| LOT# NKM701776H| IMPLANTED:| LEAD: MODEL 3387, LOT# N24859B| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0090297N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0343679V| PROGRAMMER: MODEL 37642, LOT# NJZ102431N| EXTENSION: MODEL 7482, LOT# NHU045697V| EXPLANTED:| ADAPTER: MODEL 64001, LOT# N246544| EXPLANTED:| EXPLANTED: