BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4552545 · Received February 26, 2015

    Report

    Report Number
    3004209178-2015-03786
    Event Type
    Injury
    Date Received
    February 26, 2015
    Date of Event
    December 20, 2014
    Report Date
    February 3, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 60 HOURS AFTER PUMP WAS REPLACED, THE PATIENT WENT THROUGH WHAT THEY THINK WAS WITHDRAWAL. AT THE REPLACEMENT SURGERY, THE MANUFACTURE REPRESENTATIVE WAS PRESENT. THE PHYSICIAN WAS ASKED TO CHECK MEDICATION, THE PUMP WAS EMPTIED AND FILLED. THE CATHETER WAS EMPTIED OF LESS THAN 1CC OF DRUG AND CEREBRAL SPINAL FLUID (CSF). THE PUMP WAS PRIMED TO TIP AND STARTED TO PREVIOUS DOSE. IT WAS NOTED THAT NOTHING UNUSUAL HAPPENED DURING THE PROCEDURE. A MEDICAL INTERVENTION WAS DONE. THEY WERE TRYING TO FIGURE OUT IF THE CONCENTRATION WAS RIGHT. THE PATIENT HAD UNDER-DOSE SYMPTOMS AND LESS THAN 50% THERAPY RELIEF. THE PATIENT WAS OUT OF WITHDRAWAL PERIOD (THE PATIENT WENT THROUGH WITHDRAWAL-NO SPECIFIC SYMPTOMS WERE MENTIONED) BUT REMAINED VERY SPASTIC AND NOT CONTROLLED. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING EFFECTIVE THERAPY AND BACK TO PRE-IMPLANT SPASTICITY. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS "ALIVE-NO INJURY." THE PUMP SYSTEM WAS DELIVERING GABLOFEN. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136235 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Other