BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1000053 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00688
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 15, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS CONFIRMED BY ROTOR STUDY IN 2008. THE PUMP CONTAINED MORPHINE AND COMPOUNDED BACLOFEN. THE HCP REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS INCLUDING THE FOLLOWING: HYPERTONIA, NAUSEA, VOMITING, INCREASED PAIN, AND SPASTICITY. THE PUMP WAS EXPLANTED AND REPLACED; THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT#UNK| IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709 LOT# J11658R51