BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4182898 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19959
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2021
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A GRADUAL ONSET OF INCREASED SPASTICITY AND PAIN SINCE (B)(6) 2014. DESPITE DOSING INCREASES THE SYMPTOMS PROGRESSED. THERE HAD BEEN NO VOLUME DISCREPANCIES AT REFILLS. THE PUMP WAS CHECKED AND THERE WERE NO ALARMS ACTIVE OR IN THE PAST. THE CATHETER WAS CHECKED FOR PATENCY AND WAS ASPIRATED WITH SUCCESS. A SINGLE BOLUS OF BACLOFEN WAS GOING TO BE DONE AFTER A PRIMING BOLUS TO EVALUATE THE PATIENT RESULTS. THE SYSTEM WAS BEING USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING INCREASED SPASMS. IT WAS NOTED TROUBLESHOOTING AND INTERVENTIONS INCLUDED DOSE ADJUSTMENTS, SIDE PORT ASPIRATION, AND SURGERY. THERE WAS A PUMP REPLACEMENT AND CATHETER REVISION. FURTHER INFORMATION WAS NOT PROVIDED AND THE CAUSE OF THE EVENT WAS NOT SPECIFIED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IF ADDITIONAL IN FORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661383 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention "SEE H10...."