BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2945691 · Received February 6, 2013

    Report

    Report Number
    3007566237-2013-00381
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 25, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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

    NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK-BASED ANALYSIS CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 64002, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION OF THE PATIENT'S ACTIVE PC AND POCKET ADAPTOR AND AN EXPLANT WAS PLANNED. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED AS A REPLACEMENT TO A KINETRA THAT WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. IT WAS FURTHER NOTED THAT THE SIZE OF THE DEVICE AND POCKET ADAPTOR EXCEEDED THE CAPACITY OF THE SKIN AND THIS PROBABLY CAUSED THE INFECTION. THE PATIENT STATUS WAS NOTED AS ALIVE-WITH INJURY AND ACTION HAD NOT BEEN TAKEN YET, BUT AN EXPLANT WAS PLANNED. IT WAS ALSO NOTED THAT ACTIONS REQUIRED INCLUDE "HOSPITALIZATION" AND "INTERVENTION REQUIRED SURGICAL." SYMPTOMS WERE NOTED AS FEVER AND THE LOCATION WAS STATED TO BE THE DEVICE POCKET. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION WAS AT THE INS POCKET AND THE ORGANISM WAS (B)(6). THE SYSTEM WAS EXPLANTED AND THE PATIENT WAS BEING TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51286 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention