BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2831999 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10255
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, SERIAL# UNKNOWN, IMPLANTED: UNKNOWN, EXPLANTED: UNK. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A MOTOR FEEDTRU ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING AS OF THE DATE OF THIS REPORT. IT WAS ADDED THAT IT HAD STARTED THAT MORNING. THE PUMP WAS INTERROGATED AND THE LOGS REVEALED MULTIPLE MOTOR STALLS AND RECOVERIES. IT WAS BELIEVED THAT ANOTHER MOTOR STALL MAY LEAD TO A PERMANENT STALL AND THE DECISION WAS MADE TO ADMIT PATIENT TO REPLACE PUMP. THE PUMP WAS REPLACED THE NEXT DAY. THE REASON FOR REMOVAL WAS STATED AS "BATTERY DEPLETION EARLY." THE PUMP LOGS WERE CHECKED AND INDICATED THAT THE LAST MOTOR STALL HAD OCCURRED WITH NO RECOVERY; "RESET OCCURRED-LOW BATTERY" WAS ALSO NOTED. PATIENT OUTCOME WAS REPORTED AS FULLY RECOVERED WITHOUT INJURY. THE SYSTEM WAS USED TO INFUSE BACLOFEN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 00025 YR Required Intervention