BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203459 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04461
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 5, 2012
    Report Date
    August 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8 590-1 LOT# N316580, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT¿S WIFE REPORTED THAT THE PATIENT GOT IMPLANT IN (B)(6) AND THE HCP WERE SLOWLY INCREASING HIS SETTINGS AND PATIENT HAD BEEN IN HORRIFIC PAIN. STATED PATIENT WAS TAKEN OFF ALL ORAL MEDICATIONS AND HCP WANTED PATIENT TO RELY ON PUMP. PATIENT WENT IN TO HCP WEEKLY TO GET A SLOW INCREASE IN DOSAGE BUT YET HIS PAIN HAD BEEN A RATING OF 8. AFTER THE PAIN RELIEF WEARS OFF THE PATIENT ENDED UP IN BED. CALLER STATED HCP DID NOT KNOW HOW LONG COULD TAKE FOR PATIENT TO REACH THE PAIN RELIEF BUT THERE COULD BE A LONG WAY. PATIENT WAS ON ORAL METHADONE WHEN PUMP WAS IMPLANTED AND THE INTENTIONS WERE TO INCREASED PUMP THERAPY AND DECREASE THE METHADONE. AFTER EVERY DOSAGE INCREASE THE RELIEF MIGHT LAST UP TO 4 DAYS MAXIMUM. SHE STATED PATIENT WAS ON ½ METHADONE PILL VERSUS WHERE HE STARTED. SHE INDICATED HCP EXPLAINED THE MAXIMUM DOSAGE INCREASE AT A TIME IS 22% BUT USED CAUTION BECAUSE URINARY SYSTEM. PATIENT COULD SOMETIME FEEL THE CHANGE, SOMETIMES HE COULDN¿T. SHE NOTED, THE PATIENT WAS ON HIS CRUTCHES AND HAS SUICIDAL THOUGHTS ¿ HE SAID, HE WAS GOING TO KILL HIMSELF. INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE ABOUT TWO MONTH AFTER REPORTED EVENT INDICATED THE PATIENT WAS IMPLANTED WITH THE PUMP ON (B)(6) 2012. THE IMPLANT WAS SUCCESSFUL, AND WITHOUT INCIDENT. THE SYSTEM WAS USED TO DELIVER MORPHINE. CONCENTRATION WAS NOT INDICATED. REPRESENTATIVE INDICATED RECEIVING A CALL FROM PATIENT¿S WIFE SEVERAL DAYS AFTER SURGERY IN WHICH SHE EXPRESSED PATIENT¿S SITE PAIN/DISCOMFORT. IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302649 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR