BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1833160 · Received September 9, 2010

    Report

    Report Number
    3007566237-2010-06887
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO A MOTOR STALL. THE PUMP CONTAINED PETHIDINE (DEMEROL) AT A CONCENTRATION OF 50 MG/ML ADMINISTERED AT 50MG/DAY. NO ROTOR STUDY WAS PERFORMED AND NO DYE STUDY WAS PERFORMED. IT WAS UNK IF THE DATA LOGS WERE ACCESSED BY THE DOCTOR. IT WAS UNK IF THERE WERE ANY SYMPTOMS. THE PT RECOVERED WITHOUT SEQUELA.

    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