BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3190002 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10889
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V700663, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V700663, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN INFECTION. IT WAS NOTED THAT A CULTURE WAS TAKEN FROM THE DEVICE POCKET. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND BOTH EXTENSIONS WERE EXPLANTED ON (B)(6) 2013. THE PATIENT HAD COME INTO THE OPERATING ROOM FOR A POSSIBLE REVISION AND WHEN THE INS POCKET WAS OPENED THERE WAS A COLLECTION OF PUS. IT WAS NOTED THE LEADS REMAINED IMPLANTED FOR FUTURE IMPLANTATION OF A NEW SYSTEM AT AN UNKNOWN DATE. IT WAS REPORTED THE PATIENT EXPERIENCED A BURNING SENSATION, FEVER AND SWELLING AT THE DEVICE POCKET. ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR THE POSSIBLE REPLACEMENT WAS THE EXTENSIONS WERE TOO TIGHT. LAB WORK RESULTS FOUND THE POCKET WAS POSITIVE FOR A STAPHYLOCOCCAL INFECTION. IT WAS NOTED THE PATIENT ALSO EXPERIENCED DRAINAGE AROUND THE EXTENSION AND DISCOMFORT AROUND THE EXTENSION SITE. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291625 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention