BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874465 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11870
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 14, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRATHECAL PUMP WAS UNABLE TO BE REFILLED, AND THE PHYSICIAN ATTEMPTED TO REVISE THE POCKET AND SECURE THE PUMP. IT WAS DISCOVERED THE PUMP WAS ACTUALLY PLACED ORIGINALLY BELOW THE ABDOMINUS RECTUS MUSCLE. WHEN THE PHYSICIAN OPENED THE PUMP POCKET, HE FOUND THAT THE PUMP HAD ERODED THROUGH THE ABDOMINAL VISCERA AND WAS FLOATING BENEATH THE FASCIAL LAYER IN THE ABDOMEN. A GENERAL SURGEON WAS CALLED IN TO FURTHER DISSECT THE ABDOMEN, RETRIEVE THE ERODED PUMP, AND CLOSE THE ABDOMINAL MUSCLE LAYER. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS ALIVE WITH NO INJURY OR NO ADVERSE EVENT. DRUG DELIVERED VIA THE DEVICE WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention