BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2950021 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01454
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 18, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V530284, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS EXPLANTED POSSIBLY DUE TO INFECTION. IT WAS ALSO STATED THAT THE INS WASN'T WORKING WELL FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54305 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention