BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1051628 · Received May 21, 2008

    Report

    Report Number
    2182207-2008-02675
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P86004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR 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 PUMP LOGS SHOWED A MOTOR STALL AND RECOVERY OCCURRED IN 2007. IN 2008, THE PUMP LOGS SHOWED 'RESET OCCURRED - LOW BATTERY', 'RESET OCCURRED', AND 'SAFE STATE' MESSAGES. THE PT PRESENTED TO CLINIC WITH A RETURN OF SYMPTOMS ON FIFTEEN DAYS LATER; HIS PUMP WAS FOUND TO BE ALARMING AND IN SAFE STATE MODE. THE PUMP LOGS ALSO REVEALED A 'MOTOR STALL RECOVERY' MESSAGE. THE ERRORS HAD NOT OCCURRED DURING PUMP UPDATE OR INTERROGATION; NO SOURCE OF ELECTRO-MAGNETIC INTERFERENCE WAS IDENTIFIED. THE PT HAD BEEN HOSPITALIZED SEVERAL WEEKS FROM LATE 2007 TO 2008 (REASON NOT REPORTED). THE PUMP WAS REPLACED BASED ON PUMP INTERROGATION DATA. THE HCP REPORTED THAT THE PT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER MORPHINE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 8711 LOT# N084155001| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED