BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872377 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07813
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT INDICATED SHE FELT WEAK ON THE UPPER PART OF HER BODY. PT'S PUMP WAS TO HELP WITH STIFFNESS AND HER LEGS SEEMED TO BE DOING OKAY. THE PT HAD AN X-RAY AND THE DOCTOR INDICATED THAT THE CATHETER HAD MOVED UP A LITTLE BIT. PT STATED PHYSICIAN DID NOT THINK THIS COULD BE CAUSING THE SYMPTOMS. THE PT WAS HOME AND CONSIDERING A SECOND OPINION. PT NOTED IMAGING WAS PERFORMED AND THAT A PROBLEM WAS FOUND. AT THE TIME OF THIS REPORT, NO FURTHER INFO WAS REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N124970034