BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2667140 · Received July 24, 2012

    Report

    Report Number
    3004209178-2012-06006
    Event Type
    Injury
    Date Received
    July 24, 2012
    Report Date
    June 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (MODEL # 3387-40, LOT # V000525) FOUND NO SIGNIFICANT ANOMALY. OUTER INSULATION SEPARATED AT BUTT JOINT ON THE DISTAL END AT ELECTRODE #3. PROXIMAL END OF LEAD NOT RETURNED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER; PRODUCT ID 3387-40, LOT # V000525, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # V000525, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 EXPERIENCED A SEIZURE WITH STIMULATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE SYMPTOMS. THE PATIENT HAD A HISTORY OF FALLS BUT NONE SPECIFICALLY RELATED TO THIS INCIDENT. THE PATIENT WOULD USUALLY FALL STRAIGHT OVER. IT WAS REPORTED THAT THE LEAD WAS VISIBLY DAMAGED, AND THAT THE LEAD HAD MIGRATED FURTHER INTO THE BRAIN, POSSIBLY INTO THE HIPPOCAMPUS BUT THE MANUFACTURER'S REPRESENTATIVE WASN'T SURE. FILMS WERE TAKEN WHICH SHOWED THE LEAD WAS BENT INSIDE THE BRAIN. UPON EXPLANT IT WAS NOTED THAT THE INSULATION BETWEEN THE ELECTRODES WAS STRIPPED AWAY. ALL ELECTRODES WERE STILL INTACT ON THE LEAD. THE LEAD WAS REPLACED WITH A NEW LEAD ON (B)(6) 2012. THE NEUROSTIMULATOR HAD NOT BEEN TURNED BACK ON YET. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention