BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3061426 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06349
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    August 21, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE COUPLING ISSUES. IT WAS STATED THAT THE PATIENT COULD "ONLY" GET 2 BARS MAXIMUM, BUT "USUALLY" HAD 0 BARS. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN IMPLANTED "TOO DEEP." IT WAS STATED THAT THE EVENT REQUIRED SURGICAL REVISION; THE INS "WILL BE MOVED TO A LESS DEEP POSITION." THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION CONFIRMED THAT THE PATIENT¿S ONLY PROBLEM WAS THAT THE RECHARGEABLE INS DEVICE WAS IMPLANTED TOO DEEP. THE DEVICE WAS EXPLANTED AND A NON-RECHARGEABLE DEVICE IMPLANTED IN ITS PLACE. IT WAS NOTED THAT THE PATIENT WAS ALWAYS WELL CONTROLLED AND RECEIVED EFFECTIVE THERAPY, AND WAS REPORTED ¿HAPPIER¿ NOW WITH THE NEW DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS DUE FOR REVISION FIVE DAYS AFTER THE REPORT, ON (B)(6). IT WAS STATED THAT IT HAD GOTTEN DELAYED. ONE WEEK LATER IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN IMPLANTED TOO DEEP. IT WAS STATED THAT THE PATIENT WAS SO PUT OFF BY THE RECHARGING EXPERIENCE, SHE DECIDED TO HAVE A NON-RECHARGEABLE INS, INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163487 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention