BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231127 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06921
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PUMP MOTOR STALL. MULTIPLE MOTOR STALLS AND RECOVERIES WERE CONFIRMED IN THE EVENT LOGS. THE PATIENT'S HEALTH CARE PROVIDER RULED OUT MAGNETS. THE CAUSE OF MULTIPLE MOTOR STALLS WAS NOT DETERMINED WHEN I LEFT THE OFFICE. THE PHYSICIAN HAD ALREADY DECREASED THE PATIENT'S DOSE AND WAS MANAGING HER IN THE HOSPITAL. THE PATIENT INDICATED THE PATIENT HAD INCREASED PAIN AND WITHDRAWAL SYMPTOMS. THE PATIENT WAS IN ICU AT THE TIME THE EVENT WAS REPORTED. 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 II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ACCESSORY: MODEL 8590-1, LOT# N133648| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11300R39