BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3151028 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08759
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 15, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8 590-1, LOT# N303824, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS TOLD THE PUMP MAY HAVE COME ¿UNSEWN ON ONE SIDE¿, IT HAD BECOME "UNSEWN" ONCE BEFORE. IT WAS FURTHER NOTED THE PATIENT WAS DIAGNOSED WITH CANCER AND LOST ¿ALL HIS UPPER TEETH¿. THE CANCER WAS UNRELATED TO THE PUMP. THE PUMP WAS USED TO DELIVER DILAUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT¿S PUMP HAD MOVED AND A REVISION WAS PERFORMED TO ¿RE-SEW IT.¿ THE PATIENT REPORTED THAT WHEN THE PUMP WAS MOVING THE PERSONAL THERAPY MANAGER (PTM) STILL WORKED. THE LAST TIME THE PUMP WAS REFILLED THE PHYSICIAN COMMENTED ¿GOOD, IT HASN¿T, IT¿S NOT MOVING.¿ IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PUMP WAS STILL UNSEWN. PER THE PATIENT THE HCP PULLED THE PUMP CLOSE ENOUGH TO THE SKIN SO HE CAN FILL IT. THE PATIENT ALSO REPORTED FOR THE 1ST TIME IN 6 OR 7 MONTHS IT IS WORKING THE WAY IT SHOULD BE. THE PATIENT STATED THE PUMP NEEDS TO BE TURNED UP MORE, THE PATIENT GOES IN EVERY WEEK. THE PATIENT GIVES HIMSELF A BOLUS JUST TO DO THE DISHES. THE PATIENT CURRENTLY GETS UP TWICE DURING THE NIGHT, HE WAS GETTING UP 3-4 TIMES A NIGHT PER THE PATIENT A CT SCAN WAS DONE AND THE PATIENT DOES NOT HAVE CANCER. BEFORE THE PUMP THE PATIENT HAD 6 SPINE SURGERIES, 4 OF THE LOWER SPINE. EVERYTHING IN THE PATIENT¿S LOW BACK IS FUSED. THE PATIENT HAD ONE HERNIATED DISC IN THE MIDDLE SECTION AND ALSO HAD A LAMINECTOMY AND HAD BAD SCOLIOSIS. THE PATIENT TRIED THE PUMP TO KEEP FROM HAVING TO HAVE ANOTHER SURGERY. THE PATIENT ALSO REPORTED DISSATISFACTION WITH THE HCP AND WAS THINKING OF FINDING A NEW HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250300 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention