BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 2052532 · Received April 11, 2011

    Report

    Report Number
    3004209178-2011-02731
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR DEVICE POCKET REVISED. ON (B)(6) 2011, IT WAS REPORTED THE PT WAS HAVING TROUBLE COMMUNICATING WITH THEIR DEVICE. AN X-RAY WAS PERFORMED, AND IT WAS DETERMINED THE PT'S DEVICE HAD BEEN IMPLANTED >1 CM DEEP, CAUSING LONGER RECHARGE TIME AND TROUBLE COMMUNICATING WITH THE DEVICE. THE POCKET WAS REVISED SO THE DEVICE WOULD SIT <1 CM DEEP. THE REVISION WAS SUCCESSFUL. THERAPY WAS RESTORED AND THE PT RECOVERED WITHOUT SEQUELA.

    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 48 YR Required Intervention EXTENSION: MODEL 37085, LOT# NKN013261V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ108313N| EXTENSION: MODEL 37085, LOT# NKN013260V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V576414| LEAD: MODEL 3387S, LOT# V576414| IMPLANTED:| ACCESSORY: MODEL 37651, LOT# NKA145969N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: