BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4173415 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19717
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE HEALTHCARE PROVIDER (HCP) CHECKED THE PUMP STATUS POST MRI AND A MOTOR STALL WAS SEEN WITH NO MOTOR STALL RECOVERY. IT WAS NOTED THAT THE PATIENT DEVELOPED ACUTE INCREASED PAIN AFTER THE MRI. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD AN MRI ON (B)(6) 2014 (YESTERDAY) AT 21:00 AND THE PUMP WAS STILL SHOWING A MOTOR STALL ON THE DAY (B)(6) 2014. IT WAS NOTED THE PLAN WAS TO CHECK THE PUMP STATUS AND LOGS AGAIN THE NEXT DAY (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MOTOR STALL RECOVERED. THE PATIENT WAS DOING GREAT AND THERE WAS NO OTHER ISSUES. THE PUMP SYSTEM WAS DELIVERING BUPIVACAINE AND MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE SECOND MOTOR STALL WAS UNKNOWN. THE PHYSICIAN WAS NOT AWARE OF ANY MRI OR ELECTROMAGNETIC INTERFERENCE (EMI) EXPOSURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS STALLED FOR LESS THAN 24 HOURS, AND THERE WAS MORE THAN ONE MOTOR STALL IN THE EVENT LOGS. IT WAS UNKNOWN IF THE REPEATED STALLS AND RECOVERIES OCCURRED IN A SHORT DURATION OR LONG DURATION. THE CAUSE OF THE MOTOR STALL WAS MAGNETIC RESONANCE IMAGING (MRI), AND THE MOTOR RECOVERED. THE PUMP WAS ALSO BEING USED TO DELIVER HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654823 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization