BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1800888 · Received August 10, 2010

    Report

    Report Number
    3007566237-2010-06015
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD WITHDRAWAL SYMPTOMS. ELEVEN DAYS LATER, IT WAS REPORTED THAT THE PT HAD A RETURN OF SPASTICITY AND PAIN IN BOTH LEGS. THE PT WAS ADMITTED TO THE HOSPITAL IN SERIOUS CONDITION WITH LYMPHEDEMA IN BOTH LEGS. THE PUMP WAS INTERROGATED AND WAS NORMAL. A CATHETER DYE STUDY WAS DONE WITH A "BUBBLE" AND A "CLOG" FOUND IN THE CATHETER. THE HEALTH CARE PROVIDER CLEARED THE "CLOG". THE PT WAS MOVED TO A REHABILITATION HOSPITAL IN FAIR CONDITION. IT WAS LATER REPORTED BY THE PT THAT THE PUMP WAS "MALFUNCTIONING." NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# N002098801| CATHETER: MODEL 8709, LOT# J11679R23| EXPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12183R29| IMPLANTED: