BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971608 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00584
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DEVICE SYSTEMS WAS IMPLANTED IN (B)(6) OF 2010. THE PT PRESENTED WITH CUTANEOUS REDDENING AT THE SPINAL SCAR LEVEL APPROXIMATELY AT THE POINT WHERE THE NEEDLE IS INTRODUCED DURING SURGERY FOR CATHETER INSERTION AND A FEVER. THE DEVICE SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE WAS REPORTED TO BE NO PT INJURY; THE PT WAS DOING "WELL" FOLLOWING THE EXPLANT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# B0951547K