BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2760604 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08540
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 11, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADD'L DEVICE: 8709SC, S/N: (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS BEEN EXPERIENCING PAIN ALL OVER HIS ENTIRE BODY FOR THE LAST THREE MONTHS THAT REQUIRED ORAL MEDICATION (LIQUID METHADONE AND OXCODONE) TO CONTROL. A DYE STUDY WAS PERFORMED A WEEK AGO THAT SHOWED THE CATHETER HAD 'PULLED OUT AND CURLED UP.' THE PATIENT BELIEVES THIS OCCURRED AS A RESULT OF SNEEZING 2-3 MONTHS AGO. A CATHETER REVISION WAS PLANNED FOR THE NEAR FUTURE. DRUG IN THE PUMP WAS MORPHINE.

    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