BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2190730 · Received July 26, 2011

    Report

    Report Number
    3007566237-2011-05798
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    V
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARM WAS SOUNDING. THE ALARM WAS NOT CONFIRMED BY TELEMETRY. THE PATIENT HAD NOT EXPERIENCED ANY WITHDRAWAL SYMPTOMS. THE PATIENT HAD MISSED A REFILL (DATE NOT REPORTED). WITHDRAWAL WAS REPORTED. THE PATIENT HAD MISSED THE REFILL INTENTIONALLY. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other