BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013498 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04006
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 20, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WAS A GEAR TRAIN ANOMALY FOUND AND INDICATED AS CORROSION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD FELT SYMPTOMS OF AN UNDER DOSE AND WITHDRAWAL A FEW WEEKS AGO. THE PATIENT'S PUMP WAS INTERROGATED AND IT WAS DISCOVERED THAT THE PUMP HAD STALLED BUT HAD RESTARTED. THE PATIENT CONTINUED TO HAVE INTERMITTENT FEELINGS OF WITHDRAWAL AND UNDER DOSE SYMPTOMS; INCREASED SPASTICITY AND "FIDGETY." THE PATIENT WAS OBSERVED TO HAVE BEHAVED STRANGELY AND APPEARED SICK. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2013. A REVIEW OF THE LOGS NOTED A FEW MOTOR STALLS AND SUBSEQUENT RESTARTS. THE LONGEST STALL HAD LASTED MORE THAN EIGHT HOURS. THIS DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. NO PATIENT INJURY WAS REPORTED AND THE PUMP WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116162 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention