BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3608892 · Received February 5, 2014

    Report

    Report Number
    3004209178-2014-01619
    Event Type
    Injury
    Date Received
    February 5, 2014
    Date of Event
    November 14, 2013
    Report Date
    January 17, 2014
    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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RETURNED FOR ANALYSIS WAS THE PUMP AND THE CATHETER. HERE WAS MOTOR STALL RECOVERY IN THE LOGS. AFTER DOING FURTHER ANALYSIS THE TECHNICIAN FOUND NOTHING SIGNIFICANT THAT MAY CAUSE THE MOTOR STALL. ANALYSIS OF THE PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION. CATHETER WAS RETURNED INCOMPLETE IN SEGMENTS; ANALYSIS OF THE SAME REVEALED NO SIGNIFICANT ANOMALY. A NON-SIGNIFICANT INDENT WAS SEEN DOWN IN THE CUP OF THE SC CONNECTOR.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N213450, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN PAIN AND SPASMS OF A MODERATE SEVERITY. ON (B)(6), A CATHETER ACCESS PORT (CAP) CONTRAST STUDY WAS PERFORMED AND IT WAS SEEN THAT THE DYE WAS GOING INTO THE POCKET, NOT THE CEREBROSPINAL FLUID. IT WAS INDICATED THAT THE CODMAN ANCHOR BROKE AND THE CATHETER HAD WORKED ITSELF BACK INTO THE POCKET. THE CATHETER WAS LATER REPLACED AND THE EVENT RESOLVED WITHOUT SEQUELA THAT SAME DAME. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74123 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention