BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2980228 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03106
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 31, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709, LOT# L70456, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING A PUMP REPLACEMENT, THE PATIENT HAD NOT "FELT THE SAME". IT WAS NOTED THAT THE PATIENT WAS FEELING "JITTERY" AND HEARD THE PUMP BEEP. UPON INTERROGATION, IT WAS FOUND THAT THE PUMP WAS IN SHELF-STATE. THE PUMP HAD NOT BEEN UPDATED AFTER THE REPLACEMENT, SO IT WAS SEEN THAT THE PUMP WAS RUNNING AT MINIMUM-RATE AND THERE WAS NO CATHETER INFORMATION PROGRAMMED. ADDITIONALLY, IT WAS UNKNOWN IF THERE WAS DRUG IN THE PUMP, AS THE PROGRAMMING STATED THAT THE PUMP WAS INFUSING WATER. AT THE TIME OF REPORT, THE PHYSICIAN WAS CONSIDERING PUTTING THE PATIENT ON ORAL MEDICATIONS AND SENDING HER BACK TO THE SURGEON. LATER THAT DAY, IT WAS REPORTED THAT THE PHYSICIAN FOUND THE CATHETER INFORMATION AND FILLED THE PUMP WITH LIORESAL. IT WAS DECIDED THAT NO PRIMING BOLUS WOULD BE PERFORMED AT THAT TIME. THE PATIENT HAD NOT EXPERIENCED ANY WITHDRAWAL THROUGHOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84415 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1