BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4243848 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21342
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 23, 2014
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS REPLACED ON (B)(6)-2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM WAS HEARD AND WAS CONFIRMED BY TELEMETRY. THE PUMP LOGS SHOWED ONE STALL OCCURRING ON OCTOBER 21ST AT 3:12AM AND RECOVERING AT 5:24AM. FOLLOWING THAT, MULTIPLE MOTOR STALLS AND RECOVERY MESSAGES WERE SEEN, WITH THE LAST MESSAGE BEING A MOTOR STALL RECOVERY ON THE DAY OF REPORT. AT THE TIME OF REPORT, THE PATIENT HAD SOME ¿SNIFFLES, BUT NOTHING SERIOUS¿. IT WAS NOTED THAT REPORTER PLANNED TO CONTACT A NEUROSURGEON. THE DEVICE SYSTEM HAD BEEN DELIVERING CLONIDINE AND MORPHINE. THERE HAD BEEN NO KNOWN INTERVENTIONS PERFORMED AND THE EVENT HAD YET TO RESOLVE AS OF THE PREVIOUSLY REPORTED INFORMATION. FURTHER FOLLOW-UP WAS REQUESTED TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725845 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention