BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 2638552 · Received July 3, 2012

    Report

    Report Number
    3004209178-2012-05146
    Event Type
    Death
    Date Received
    July 3, 2012
    Report Date
    June 6, 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
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR SERIAL # (B)(4) FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION SERIAL # (B)(4) FOUND THAT THE CONDUCTOR BODY WAS CUT. ANALYSIS OF THE EXTENSION SERIAL # (B)(4) FOUND THE EXTENSION BODY'S OUTER INSULATION WAS CUT. ANALYSIS OF THE LEAD LOT # V050299 FOUND THAT THE PROXIMAL END OF THE CONDUCTOR WAS BROKEN DUE TO OVERSTRESS/DAMAGE. ANALYSIS OF THE LEAD LOT # V157361 FOUND THAT THE PROXIMAL END OF THE CONDUCTOR WAS BROKEN DUE TO OVERSTRESS/DAMAGE. NO SIGNIFICANT ANOMALIES WERE FOUND FOR THE LEADS AND EXTENSIONS.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51 SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED:; PRODUCT TYPE EXTENSION PRODUCT ID 7482A51 SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED:; PRODUCT TYPE EXTENSION PRODUCT ID 7436 SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40 LOT# V050299 IMPLANTED: EXPLANTED:; PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V157361 IMPLANTED: EXPLANTED:; PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V050299 IMPLANTED: (B)(6) 2008 EXPLANTED:; PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V157361 IMPLANTED: (B)(6) 2008 EXPLANTED:; PRODUCT TYPE LEAD. (B)(4). 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

    NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS COMPLICATIONS OF PARKINSON'S DISEASE. INFORMATION AS TO WHETHER OR NOT THE DEATH WAS DEVICE RELATED WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Death