BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112534 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07669
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT # N171980007, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND A GEAR TRAIN ANOMALIES. CORROSION AND/OR WEAR AND/OR LUBRICATION WAS SEEN ALONG WITH A STALL DUE TO GEAR WHEEL 3. THE TEETH OF GEAR WHEEL 3 HAD SIGNIFICANT CORROSION AND WERE BARELY/NOT TOUCHING THE PUMP HEAD GEAR. IT WAS NOTED THIS WAS LIKELY THE POSSIBLE CAUSE OF THE MOTOR STALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER UPON INTERROGATION NOTED A MOTOR STALL HAD OCCURRED AND NO MOTOR STALL RECOVERY WAS NOTED. IT WAS NOTED THE PUMP HAD BEEN STALLED FOR LESS THAN 48 HOURS AS THE REPORTER HAD NOT YET SEEN A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE WHILE REVIEWING THE LOGS. THE REPORTER THOUGHT THE DEVICE SYSTEM HAD BEEN USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THE PUMP HAD BEEN ALARMING AND THE PATIENT WENT TO THE EMERGENCY ROOM (ER) TO HAVE THE PUMP INTERROGATED. UPON INTERROGATION, A MOTOR STALL ON (B)(6) 2013 ALONG WITH "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" ON (B)(6) 2013 WERE SEEN. THE PATIENT REPORTEDLY HAD A "SLIGHT" RETURN OF SPASTICITY AND WAS BEING MANAGED MEDICALLY. IT WAS REPORTED THE PATIENT HAD NOT HAD AN MRI AND WAS NOT DUE TO BE REFILLED FOR A LONG TIME. THE PATIENT WAS "HEADING BACK" TO THE ER FOR FURTHER EVALUATION AND IT WAS NOTED "THEY'RE GOING TO TRY TO JUST RESET THE DOSE AND START IT AGAIN." IT WAS LATER REPORTED THE PUMP HAD BEEN INTERROGATED AND THEN RESTARTED. AFTER, RE-UPDATING, THE PHYSICIAN PROGRAMMER SHOWED A MOTOR STALL OCCURRED MESSAGE AGAIN. IT WAS NOTED "NO PATIENT EVENTS, NO MRI, PATIENT WAS SENT HOME WHEN STALL OCCURRED WITH NO ADVERSE EVENTS OR ACTIVITIES THAT COULD BE ASSOCIATED WITH A STALL." THE REPORTER HAD REPORTEDLY BEEN UNAWARE THAT WHEN THE MOTOR STALL MESSAGE APPEARED THAT MEANT THE PUMP WAS STILL STALLED VERSUS RUNNING AGAIN. IT WAS REPORTED, "WE AREA WAITING REPLACEMENT SURGERY. PATIENT IS ADMITTED AND MANAGED ON ORALS UNTIL DETAILS AND ALL MEASURES ARE EXHAUSTED PRIOR TO REPLACEMENT SURGERY." IT WAS LATER REPORTED A ROTOR STUDY AND DYE STUDY HAD NOT BEEN PERFORMED. THE PUMP WAS EXPLANTED. IT WAS REPORTED NO PATIENT INJURY HAD OCCURRED. IT WAS LATER REPORTED THE PATIENT WAS IMPLANTED "WITH NEW PUMP AND HOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213080 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R