BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093629 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03472
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF HER SYMPTOMS. THE SYMPTOM REPORTED WAS INCREASED BASELINE PAIN. THE PT'S SYMPTOMS ARE IN HER LEFT LEG. THE SYMPTOMS BEGAN AFTER A PROGRAMMING SESSION. THE PT WAS ADMITTED TO THE HOSPITAL. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization IMPLANTED:| CATHETER: MODEL 8709, LOT# J55518R28| EXPLANTED: