BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2914466 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00575
    Event Type
    Death
    Date Received
    January 14, 2013
    Date of Event
    February 2, 2012
    Report Date
    February 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND THERE TO BE NO ANOMALIES. ANALYSIS OF THE CATHETER FOUND IT TO BE SEGMENTED AND PARTIALLY RETURNED. PRODUCT ID 8709SC, SERIAL,# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8591-38, LOT # D13674, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8590-1, LOT # N310345, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A PATIENT DEATH WAS REPORTED. THE PATIENT DIED OF AMYOTROPHIC LATERAL SCLEROSIS. THE PATIENT WAS SEEN LAST BY HER PUMP PHYSICIAN ON (B)(6) 2012 FOR A POST-OPERATIVE EXAM. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF INFECTION. THE PATIENT HAD A SEROMA IN HER POST LUMBAR INCISION. THE PATIENT WAS EXPECTED BACK IN THREE WEEKS FOR FOLLOW-UP. THERE WAS NO CONFIRMATION ON WHETHER OR NOT THE DEVICE/THERAPY WAS RELATED TO THE PATIENT'S DEATH. THE DRUG IN THE PUMP WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20154 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death