BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1081361 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04358
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    April 1, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED ACUTE PAIN AND NUMBNESS OF HER ENTIRE RIGHT SIDE EACH TIME SHE ACTIVATED A BOLUS DOSE VIA PT THERAPY MONITOR. THE PT STATED IT REMINDED HER OF "DROP FOOT". THIS BECAME MORE NOTICABLE IMMEDIATELY POST-IMPLANT. THE PT ALSO EXPERIENCED SHAKING, CHILLS, NAUSEA AND VOMITING DURING THE NIGHT; SHE STILL DID NOT FEEL WELL IN THE MORNING. LATER THAT DAY, SHE AGAIN EXPERIENCED SHAKING AND PRESENTED TO THE ER. IT IS UNK WHAT TREATMENT WAS PROVIDED TO THE PT. THE PT HAS HEARD AN ALARM AND CONTINUED TO EXPERIENCE LACK OF THERAPEUTIC BENEFIT. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| PROGRAMMER MODEL 8832 LOT# NJG005897N| IMPLANTED:| CATHETER MODEL 8709SC LOT# N144272005