BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3350889 · Received September 16, 2013

    Report

    Report Number
    3004209178-2013-16340
    Event Type
    Injury
    Date Received
    September 16, 2013
    Report Date
    August 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389S-40, LOT# V993984, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37085-60, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V985676, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEVERE INFECTION IN THE BRAIN SURROUNDING THE LEFT LEAD ¿AT SOME POINT¿ AFTER IMPLANT. THE LEAD WAS EVENTUALLY REMOVED AND AT THE TIME OF THE REPORT, THE PATIENT WAS SUFFERING FROM SUBSTANTIAL COGNITIVE AND MENTAL DEFICIT. THE PATIENT WAS BEING TREATED FOR ¿BRAIN INJURY,¿ POST-INFECTION TREATMENT, AND A BRAIN ABSCESS. THE PATIENT¿S WIFE STATED THAT HER HUSBAND WAS STILL SUFFERING FROM THE INFECTION. ANTIBIOTICS TREATMENT WAS NECESSARY AND THE PATIENT HAD AN ALTERED MENTAL STATUS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465113 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S