BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3953761 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13457
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NO ALLEGED PRODUCT ISSUES ON THE PUMP OR CATHETER. IT WAS NOTED THAT THE PATIENT WAS WEANED OFF BACLOFEN AND SALINE WAS PUT IN THE PUMP. IT WAS NOTED THAT THE PATIENT HAD LESS THAN 50% THERAPY RELIEF IN THE LEGS. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN IMPRESSED WITH RESULTS OVER THE YEARS WITH THEIR PUMP. THE PATIENT IS NON-AMBULATORY AND DID NOT FEEL THEIR SPASTICITY IMPEDED HER TRANSFERS. IT WAS NOTED THAT THE PATIENT REQUESTED THEIR DOSE TO BE WEANED DOWN; WHICH IT WAS. THE PATIENT HAD SALINE IN THEIR PUMP AND DID NOTICE SOME RETURN OF BASELINE SPASTICITY BUT DID NOT FEEL IT IMPEDED HER AND REQUESTED THE PUMP BE EXPLANTED. THE PATIENT WAS PLACED ON ORAL BACLOFEN. THE PUMP SYSTEM WAS EXPLANTED ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN ON GABLOFEN AT THE TIME THAT THEY HAD STARTED TO TITRATE DOWNWARD AND SWITCH TO SALINE. IT WAS NOTED THAT THE PATIENT FELT THE PUMP HAD NOT BEEN EFFECTIVE FOR HER LONG TERM AND ALSO COMPLAINED OF HAVING TRANSPORTATION ISSUES GETTING TO THE CLINIC FOR REFILLS AND DOSE ADJUSTMENTS, SO THE PATIENT DESIRED TO HAVE IT REMOVED. IT WAS NOTED THAT THE PATIENT WAS STABLE AND DISCHARGED FROM THE HOSPITAL AFTER POST-EXPLANT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS ¿NO ORAL ANTI-SPASTICITY MEDICATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431158 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention