BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032470 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02312
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2009
    Report Date
    March 11, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S CATHETER HAD DISLODGED, AND HAD COILED BEHIND THE PUMP. THE CATHETER WAS REVISED ON (B)(6) 2009. THE PUMP WAS NOT REPLACED AT THE TIME OF THE CATHETER REVISION. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L 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 54 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N200075013| IMPLANTED:| EXPLANTED: