BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203546 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04770
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    November 2, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER 8835, SERIAL# (B)(4), IMPLANTED: NA, EXPLANTED: NA; CATHETER MODEL 8731 SERIAL# (B)(4), IMPLANTED: 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED ¿SO MUCH PAIN¿ AND WAS ¿HOME BOUND AND BED BOUND.¿ SHE DIDN¿T THINK HER MEDICATION WERE WORKING AND ASKED HER PHYSICIAN TO RUN DYE THROUGH HER CATHETER BUT SHE WAS NOT SURE HE DID THAT. IT WAS LATER REPORTED THAT SHE HAD GRADUALLY RECEIVED LESS AND LESS PAIN RELIEF AND THAT SHE HAD BECOME ¿MATERIALLY WORSE¿ AND HAD TO HAVE ¿MAJOR¿ BACK SURGERY IN (B)(6) 2012 WHERE THE DOCTOR WAS ¿PUTTING DRILLS AND EVERYTHING IN THERE AND WHAT NOT AND HAD TO TWIST HER L3 DISK VERY VIOLENTLY¿ BECAUSE WHEN THE DISK HERNIATED IT MADE HER ¿WHOLE SPINE GO OUT, ALL THE WAY UP TO T1.¿ IT WAS ¿ESPECIALLY¿ AFTER THE NON-PUMP RELATED SURGERY IN (B)(6) 2012 THAT THE PATIENT NOTICED A DECREASE IN PAIN RELIEF. IT WAS ALSO REPORTED THAT THE PATIENT WAS TRYING TO FIND A NEW PAIN DOCTOR AND WAS WORKING WITH HER PRIMARY PHYSICIAN TO GET AN IMAGING ORDER FOR THE PUMP. NO RESULTS OF THE IMAGING WERE REPORTED. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL, BACLOFEN (UNKNOWN), DILAUDID (HYDROMORPHONE), AND MARCAINE (BUPIVACAINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306209 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR