BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3936019 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13040
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 23, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J11176R59, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (SN (B)(4)) FOUND THE PUMP HEAD HAD A HOLE IN THE PUMP TUBE FROM MECHANICAL WEAR. ANALYSIS ALSO FOUND A MOTOR FEED THROUGH ANOMALY CAUSED BY SHORTING ACROSS THE INSULATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A CRITICAL ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE CRITICAL ALARM WAS OCCURRING DUE TO A MOTOR STALL. THE STALLS WERE INTERMITTENT AND REPEATED. IT WAS NOTED THE PATIENT SLEPT ON A MOTORIZED BED. THE PATIENT WAS NOTED TO HAVE BEEN AT DINNER DURING ONE OF THE STALLS. THE PATIENT HAD SOME NAUSEA BUT WAS NOT SURE IF IT WAS RELATED TO THE PUMP OR DUE TO ORAL MEDICATIONS. THE PUMP CONTAINED BACLOFEN, BUPIVACAINE AND ANOTHER DRUG. IT WAS FURTHER REPORTED THE PATIENT BEGAN TO HEAR "ONE LONG BEEP" A COUPLE MONTHS AGO AND IT HAPPENED ONCE A MONTH. THE PATIENT BEGAN TO HEAR A DUAL TONE BEEP AT THE BEGINNING OF THE WEEK. ALSO HEARD IT ON FRIDAY, ONCE SATURDAY AND TWICE TODAY. POTENTIAL WITHDRAWAL WAS ALSO REPORTED. THE PATIENT HAD FLU-LIKE SYMPTOMS AND FOR THE PAST 2 MONTHS, THE PATIENT HAD BEEN VOMITING EVERY DAY. THE PATIENT WAS ALSO FEELING "LOUSY". THE OTHER DRUG IN THE PUMP WAS REPORTED TO BE DILAUDID.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR PUMP AND CATHETER REMOVED DUE TO A "GROWTH IN THE PATIENT'S SPINE." THE CATHETER NEEDED TO BE REMOVED SO THEY COULD "GET AT THE GROWTH." THEY DECIDED TO REMOVE THE WHOLE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413967 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention