BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2230448 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06338
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR AND EXTENSIONS WERE EXPLANTED AND REPLACED DUE TO INFECTION. THE INFECTION-CAUSING ORGANISM WAS NOT PROVIDED. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention "SEE H10...."| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN013210V| EXTENSION: MODEL 37085, LOT# NKN013213V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V556377| LEAD: MODEL 3387S, LOT# V606250| PROGRAMMER: MODEL 37642, LOT# NJZ108455N| LEAD: MODEL 3387S, LOT# V556377| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN013210V| EXTENSION: MODEL 37085, LOT# NKN013213V| PROGRAMMER: MODEL 37642, LOT# NJZ108455N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V606250