BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 1910974 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09908
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    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

    THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS REPLACED DUE TO INFECTION (REFERENCE MFG. REPORT 3004209178201004657). THE REPLACEMENT IMPLANTABLE NEUROSTIMULATOR ALSO BECAME INFECTION AND WAS EXPLANTED. THE HCP REPORTED THAT THE PT HAD A LOT OF OTHER UNDERLYING ISSUES. THE CAUSE OF THE INFECTION WAS UNK, BUT WAS NOT BELIEVED TO BE DEVICE-RELATED. THE HCP DIDN'T KNOW THE PT OUTCOME SINCE EXPLANT ON (B)(6) 2010.

    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 32 YR Required Intervention LOT# NFW153356H| LEAD: MODEL 3387S, LOT# V388241| LEAD: MODEL 3387S, LOT# V420219| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU203321V| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| PROGRAMMER: MODEL 37642, LOT# NJZ106535N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN000791V| IMPLANTED: