BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202377 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00090
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 5, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-8, LOT# N264695, IMPLANTED: (B)(6) 2011,PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A MOTOR STALL WAS REPORTED. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) SCAN AT AN UNKNOWN DATE AND DID NOT HAVE THE PUMP INTERROGATED AFTERWARDS. THE PATIENT EXPERIENCED ¿SOME PAIN¿ AND HAD BEEN TAKING ORAL MEDICATION. ON THE DATE OF THIS REPORT, THE PATIENT CAME IN FOR A REFILL AT WHICH TIME THE PUMP WAS INTERROGATED. THE PUMP¿S EVENT LOGS NOTED THAT A MOTOR STALL OCCURRED ON (B)(6) 2012 IT SAID, ¿STOPPED PUMP PERIOD MAY EXCEED TUBE SET.¿ A CRITICAL ALARM WAS HEARD. A ¿MOTOR STALL RECOVERY OCCURRED¿ MESSAGE WAS SEEN ON THE DATE AND AT THE TIME OF PUMP INTERROGATION. THE DRUGS IN THE PUMP WERE DILAUDID (HYDROMORPHONE) AND BUPIVACAINE. ADDITIONAL INFORMATION CONFIRMED THAT THE PUMP STALLED DURING THE MRI. IT WAS NOTED THAT THE PATIENT DID NOT EXHIBIT ANY CLINICAL SYMPTOMS DURING THIS TIME. THE PATIENT HAD BEEN BACK FOR REFILLS SINCE THIS INCIDENT AND EVERYTHING HAD BEEN APPROPRIATE IN TERMS OF VOLUMES IN THE PUMP. THE PATIENT¿S PAIN RELIEF WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301930 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR