BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2853136 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10991
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8832, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT DID NOT RECEIVE THERAPEUTIC EFFECT. THE PATIENT STATED THAT THE PUMP WAS NOT HELPING THEM ENOUGH. IT WAS LATER REPORTED IN (B)(6) 2012 THAT THE PATIENT COULD NO LONGER WALK "SINCE THE LAST PUMP REPLACEMENT." THE PATIENT WAS CURRENTLY IN PHYSICAL THERAPY AND STATED THAT SHE DID NOT LIKE THE MANAGEMENT OF HER PREVIOUS HEALTHCARE PROVIDER (HCP). IT WAS LATER REPORTED ON (B)(6) 2012 THAT THE PATIENT HAD 2 ADDITIONAL SURGERIES SINCE THE IMPLANT SURGERY DUE TO THE CATHETER COMING OUT OF HER SPINE. THE PATIENT STATED THAT THE CATHETER CAME OUT OF HER SPINE AFTER BEING IMPLANTED FOR A WEEK. THE PATIENT HAD A REVISION SURGERY AND THE CATHETER WAS PUT BACK IN THE SPINE BUT WAS NOT ATTACHED OR ANCHORED. THE CATHETER, AGAIN, CAME OUT OF THE PATIENT'S SPINE. THE PATIENT STATED THAT HER HCP DID NOT BELIEVE HER FOR 9 MONTHS. ANOTHER CATHETER REVISION SURGERY WAS PERFORMED AND DURING THIS REVISION THE CATHETER WAS "ATTACHED TO A BONE IN THE SPINE." AT THE TIME OF THE REPORT THE PATIENT WAS FEELING WEAKNESS AND HAD BEEN IN A WHEELCHAIR FOR THE LAST FIVE YEARS. THE PATIENT STATED THAT SHE HAD MULTIPLE PUMP ADJUSTMENTS WITH HER MEDICATIONS. THE PUMP WAS ADJUSTED ON (B)(6). THE PATIENT HAD 500MCG/ML BACLOFEN IN THE PUMP. THE PATIENT STATED THAT SHE WAS COMING UP ON A PUMP REPLACEMENT DUE TO BATTERY LONGEVITY. THE PATIENT WAS TO HAVE AN MRI OF THE SPINE TO CONFIRM DISEASE PROGRESSION. THE PATIENT WAS DISSATISFIED WITH HER HCP SERVICE AND STATED THAT SHE WAS TRYING TO RELY ON HER PHYSICIAN BUT THE PHYSICIAN WAS NOT HELPING. THE PATIENT STATED THAT SHE HAD SEEN 18 DIFFERENT PHYSICIANS AND WAS CURRENTLY SEEKING ANOTHER PHYSICIAN TO MANAGE THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention