BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1656218 · Received April 8, 2010

    Report

    Report Number
    3004209178-2010-02824
    Event Type
    Injury
    Date Received
    April 8, 2010
    Date of Event
    January 5, 2010
    Report Date
    March 12, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THORACIC AND MUSCLE SPASMS IN SPINE. THE PATIENT WAS PRESCRIBED ROBAXIN 500MG, 1-2 BY MOUTH THREE TIMES DAILY AND SOMA 350MG, 1 BY MOUTH THREE TIMES DAILY. THE PATIENT ALSO EXPERIENCED SEROMA AT THE LUMBAR INSERTION SITE AND A POST LUMBAR PUNCTURE HEADACHE. A LUMBAR BLOOD PATCH WAS PERFORMED ON (B) (6) 2010. THE PATIENT'S HEADACHE RESOLVED WITHOUT SEQUELAE. THE PATIENT OUTCOME WAS ONGOING EVENT; THE PATIENT WILL CONTINUE TO BE FOLLOWED IN CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709C, LOT# N223451002| PROGRAMMER: MODEL 8840, LOT# UNKNOWN