BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2873382 · Received December 14, 2012

    Report

    Report Number
    3007566237-2012-03013
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 10, 2011
    Report Date
    November 22, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED DUE TO INFECTION AT THE POCKET SITE. CULTURES WERE TAKEN BUT THE RESULTS WERE NOT REPORTED. ANTIBIOTICS WERE ADMINISTERED FOR INFECTION. BECAUSE THE PATIENT WAS WITHOUT STIMULATION THERAPY FOR THE EVENT, THEY EXPERIENCED A RETURN OF THEIR PSYCHIATRIC SYMPTOMS (DEPRESSION). IT WAS PLANNED TO RE-IMPLANT A NEW INS INTO THE PATIENT AT A LATER DATE. IT WAS NOTED THAT THE EXPLANTED INS WAS DISCARDED BY THE CUSTOMER AND WAS NOT AVAILABLE FOR ANALYSIS. THE PATIENT STATUS WAS REPORTED AS ALIVE WITH INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    INFORMATION PREVIOUSLY RECEIVED REPORTED THE ONSET OF THE INFECTION WAS (B)(6) 2012. PATIENT SYMPTOMS INCLUDED LESS THAN 50% THERAPY RELIEF. THE DATE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANT WAS (B)(6) 2012. ON (B)(6) 2012 SUICIDALITY WAS REPORTED DUE TO THE INS EXPLANT. INTERVENTIONS INCLUDED HOSPITALIZATION AND OBSERVATION. THE DATE OF RESOLUTION FOR THE EVENT WAS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| R