BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1013833 · Received March 14, 2008

    Report

    Report Number
    2182207-2008-01271
    Event Type
    Injury
    Date Received
    March 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT HAD RETURN OF SYMPTOMS (LOSS OF PAIN CONTROL). THE PUMP WAS INTERROGATED AND THE ATTENTION DIALOGUE BOX SAID, "PUMP IN SAFE STATE, RESET OCCURRED, MOTOR STALL OCCURRED, STOPPED PUMP PERIOD MAY EXCEED TUBE SET." THE PATIENT WAS BEING MANAGED WITH UNSPECIFIED ORAL MEDICATIONS. IT WAS FURTHER REPORTED THAT UPON PUMP INTERROGATION, THE MOTOR STALL, WITHOUT RECOVERY, WAS RECORDED IN THE EVENT LOGS. THE PATIENT DENIED ANY MRI ON ELECTROMAGNETIC EXPOSURE. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE. THE HCP FURTHER REPORTED THAT THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8703W LOT# L36053| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| EXPLANTED