BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2050071 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02451
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Report Date
    March 18, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PT NEVER EXPERIENCED THERAPEUTIC EFFECT AND THE PUMP "NEVER" WORKED FOR HER. THE PUMP CONTAINED NORMAL SALINE. THE PT MOVED TO (B)(6). ADD'L INFO RECEIVED REPORTED A "PUMP FAILURE"/MOTOR STALL WAS DISCOVERED 12 HOURS PRIOR TO THE PT MOVING TO (B)(6) ON A PERMANENT BASIS. THE PT PLANNED TO HAVE ANOTHER PHYSICIAN IN (B)(6) REVISE THE PUMP WHICH WAS HELPING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N231120004| IMPLANTED: