BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023432 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01733
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 19, 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
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CATHETER WAS "COILED DOWN" AND WAS OUT OF THE INTRATHECAL SPACE. THE PHYSICIAN WANTED TO SHUT OFF THE PUMP. THE PT EXPERIENCED A SEROMA. A CATHETER REVISION WAS PLANNED. THE PUMP MEDICATION WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, 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 39 YR EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N207267021| IMPLANTED: