BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 1812474 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06162
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 19, 2010
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT # 3004209178-2010-06163. IT WAS REPORTED THAT THE PT'S KINETRA DEVICE WAS EXPLANTED DUE TO A BATTERY DEPLETION ON (B)(6) 2010. HIGH IMPEDANCES WERE NOTED AFTER A SECOND KINETRA DEVICE WAS IMPLANTED. ON (B)(6) 2010, THE SECOND KINETRA DEVICE WAS REPLACED WITH AN ACTIVA RC. IT WAS STATED THAT THE ACTIVA RC WAS IMPLANTED PRIMARILY BECAUSE, THE PHYSICIAN AND PT DECIDED THEY WANTED THIS PARTICULAR DEVICE, REGARDLESS OF THE HIGH IMPEDANCE ISSUE. POST-OPERATIVE PROGRAMMING REVEALED THAT HIGH IMPEDANCES AND A LOSS OF THERAPY STILL REMAINED. THE PT'S DYSTONIC SYMPTOMS INCREASED. X-RAYS WERE DONE AND WERE NEGATIVE. THE PT HAD A REVISION SURGERY PERFORMED ON (B)(6) 2010. IT WAS FOUND THAT ONE OF THE LEADS WAS DAMAGED AND THE BATTERY WAS PERFORMING CORRECTLY. NO OTHER DETAILS OR PT OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention IMPLANTED:| LOT# NFD101778H| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NFD115254H| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU096089V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0527488V| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU096088V