BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3180070 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10642
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 31, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL PATIENT AND DEVICE CODES: (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THAT THE BATTERY HAD A REDUCED CAPACITY DUE TO BEING OVERDISCHARGED.

    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 THE PATIENT¿S DEVICE WAS IN OVERDISCHARGE (OD) AND THE PATIENT WAS NOT RECEIVING THERAPY. THE PATIENTS TREMOR HAD RETURNED. THIS WAS THE PATIENTS FIRST OD. IT WAS FURTHER REPORTED THAT A COMPANY REPRESENTATIVE COULD NOT GET ANY CHARGE INTO THE DEVICE. WHEN PALPATED, THE DEVICE FELT AS IF IT HAD EITHER SUNK OR BEEN IMPLANTED IN AN AREA BEHIND SIGNIFICANT BREAST TISSUE. THE PATIENT HAD A PREVIOUS PRIMARY CELL STIMULATOR, SO THE POCKET WAS POTENTIALLY QUITE LARGE FOR THE CURRENT STIMULATOR. THE ANTENNA LOCATE FEATURE WAS DONE WITH A LOW VALUE OF 47. AN XRAY WAS DONE. THE XRAY WAS SUSPECTED TO BE TAKEN IN AP (ANTEROPOSTERIOR) VIEW AND IF SO, IT APPEARED THE STIMULATOR HAD FLIPPED. ADDITIONAL INFORMATION/CONFIRMATION OF THE XRAY VIEW WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HAD STOPPED RECHARGING AFTER ONE MONTH OF GOOD COUPLING AND RECHARGING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS REPLACED. IT WAS NOTED THAT THE COMPANY REPRESENTATIVE WAS UNABLE TO RECHARGE THE EXPLANTED DEVICE OR APPLY THE PHYSICIAN RECHARGE MODE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BASED ON THE LOCATION OF THE RADIOPAQUE MARKER IN THE X-RAY, IT WAS SUSPECTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FLIPPED. THE REPORTER STATED THAT THE PATIENT HAD HAD AN INTERVENTION, DURING WHICH THE ADAPTOR BLOCK WAS FOUND TO BE SITTING DIRECTLY IN FRONT OF THE INS. IT WAS NOTED THAT THE ADAPTOR BLOCK WAS "TUCKED BEHIND" AND THE SITUATION WAS RESOLVED. THE REPORTER THEN STATED THAT THE PROBLEM HAD COME BACK AGAIN AND IT WAS BELIEVED THAT A SECOND SURGICAL INTERVENTION WOULD BE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280557 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention