BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2241028 · Received August 17, 2011

    Report

    Report Number
    6000030-2011-06467
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 27, 2011
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD A PUMP ALARM. THE PUMP WAS INTERROGATED AND IT WAS CONFIRMED THAT THE PUMP LOW BATTERY ALARM HAD BEEN ACTIVATED. THE PATIENT WAS ASYMPTOMATIC. THE PUMP WAS REPLACED SEVEN (7) DAYS LATER. DURING THE REPLACEMENT, IT WAS DISCOVERED THAT THE PATIENT'S CATHETER WAS NOT FULLY INTACT AND HAD A LEAK WHEN INJECTED WITH CONTRAST. THE CATHETER WAS FULLY REPLACED. THE PATIENT'S DAILY DOSE OF LIORESAL WAS REDUCED FROM 639 MCG/DAY DOSE PRIOR TO PUMP REPLACEMENT TO 150 MCG/DAY AFTER NEW PUMP IMPLANTATION. THE PATIENT WAS SEEN FOR A POST-OP APPOINTMENT ON (B)(6) 2011 AND WAS HEALING NICELY AND DOING WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER HAD BEEN CRACKED SO THEY REPLACED ALL IMPLANTED COMPONENTS. THE PATIENT REPORTED THAT THEY PUT IN A NEW CATHETER AND LEFT A PIECE OF THE OLD CATHETER IN HER SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J11403R04| EXPLANTED: