BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2963680 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02698
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 28, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL, MISSED REFILL WITH A LOW RESERVOIR ALARM AND ASSOCIATED SYMPTOMS. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. THE PATIENT MISSED A REFILL APPOINTMENT FRIDAY (B)(6) 2013, AND WAS IN THE HEALTHCARE PROVIDER (HCP) OFFICE ON THE DAY OF REPORT FOR THE REFILL, AT WHICH TIME INTERROGATION SHOWED A LOW RESERVOIR VOLUME ALARM (LRA) AND MOTOR STALL WITHOUT RECOVERY. THE LRA OCCURRED ON (B)(6) 2013 AND THE MOTOR STALL OCCURRED (B)(6) 2013. IT WAS LATER REPORTED THAT THE PUMP HAD NOT RECOVERED AND A PUMP REPLACEMENT WAS BEING SCHEDULED. THE PATIENT EXPERIENCED SYMPTOMS OF ITCHINESS, SWEATING, BEING UNABLE TO SLEEP, A RETURN OF SPASMS AND TIGHTNESS. AS OF (B)(6) 2013 THE PATIENT WAS STILL NOT RECEIVING THERAPY. THERE WAS NO TROUBLESHOOTING DONE ASSOCIATED WITH THE EVENT, AND THE CAUSE OF THE MOTOR STALL REMAINED UNKNOWN. THE MEDICATION BEING DELIVERED WAS COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS REPLACED, THERAPY HAD RESUMED AND THE PATIENT WAS DOING WELL. IT WAS NOTED THE HOSPITAL WOULD NOT RELEASE THE PUMP AND IT WAS DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69267 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention