BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 1910616 · Received November 19, 2010

    Report

    Report Number
    3004209178-2010-09841
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MDT PUERTO RICO OPEARTIONC CO., JUCNOS
    Product Code
    MHY
    PMA / PMN Number
    P960009/S05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT BEGAN TO REJECT THE DEEP BRAIN STIMULATOR AT THE POCKET SITE AFTER IMPLANT. THERE WAS NO REACTION ALONG THE EXTENSION OR LEADS. THE IMPLANTABLE NEUROSTIMULATOR ERODED OUT OF THE POCKET. THE PT WAS HOSPITALIZED; PROPHYLACTIC ANTIBIOTICS WERE STARTED. NO ALLERGIC KIT OR HISTOLOGIC TESTS WERE DONE WITH THIS PT. THE RISK OF INFECTION WAS TOO HIGH DUE TO THE OPEN WOUND OVER THE DEEP BRAIN STIMULATOR. THE IMPLANTABLE NEUROSTIMULATOR AND EXTENSIONS WERE EXPLANTED. THE LEADS REMAINED IN SITU. THE PT WAS OK AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPEARTIONC CO., JUCNOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008875V| EXTENSION: MODEL 37085, LOT# NKN008949V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008949V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008875V