BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2083029 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03262
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 13, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CATHETER FRACTURE WAS CONFIRMED. THE PUMP CONTAINED LIORESAL. THE CATHETER WAS REVISED. PT OUTCOME WAS UNK BY THE REPORTER. ADDITIONAL INFORMATION 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8711, LOT# N227948012| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N232313| IMPLANTED: