BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2201785 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06113
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC 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 INS, ADAPTOR, AND EXTENSION WERE ALL EXPLANTED ON (B)(6) 2011 DUE TO A POCKET SITE INFECTION. THE PATIENT'S SYMPTOMS INCLUDED SENSITIVITY, REDNESS AND INFLAMMATION AT THE POCKET SITE. CULTURES WERE TAKEN OF THE INFECTION. THE PATIENT WILL BE WITHOUT DBS THERAPY UNTIL A NEW DEVICE AND EXTENSION ARE REIMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 PROGRAMMER, MODEL 37642, LOT# NJZ112120N| LEAD: MODEL 3389, LOT# J0504301V| IMPLANTED:| EXPLANTED:| ADAPTER: MODEL 64001, LOT# N242693| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU058559V| EXPLANTED: