BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 13872355 · Received March 24, 2022

    Report

    Report Number
    3004209178-2022-03672
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING INTRATHECAL UNKNOWN BACLOFEN (2000 MCG/ML AT 1029.9 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT HAD AN MRI AND DID NOT HAVE THE PUMP INTERROGATED AFTER THE MRI.  IT WAS REPORTED THE PUMP READ MOTOR STALL WHEN SHE INTERROGATED IT TODAY. TELEMETRY MODE WAS REVIEWED AND RECOMMENDED RE-INTERROGATING THE PUMP. THE HCP ASKED IF SHE SHOULD PROCEED WITH THE REFILL. TECHNICAL SERVICES REVIEWED THAT SHE COULD START THE REFILL NOW OR WAIT UNTIL SHE CONFIRMED THE MOTOR STALL RECOVERY. PATIENT SYMPTOMS WERE NOT REPORTED. THE HCP CALLED BACK THE SAME DAY AND REPORTED THE LOGS SHOWED A STALL AND RECOVERY ON (B)(6) 2022 THE DATE THE PATIENT HAD AN MRI, THEN ANOTHER STALL APPEARED IN THE LOGS ALSO ON (B)(6) 2022 WITH TUBE SET ERROR ON (B)(6) 2022 (48 HOURS LATER) AND RECOVERY WAS NOTED ON TODAY'S DATE (B)(6) 2022 WHICH TECH CONFIRMED WAS EXPECTED BEHAVIOR WITH TELEMETRY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924194 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male