BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872249 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07980
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    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

    IT WAS REPORTED THAT AFTER THE PUMP WAS IMPLANTED THE "PROGRAMMER CRASHED" WHEN AN UPDATE OF THE PUMP FROM "SHELF STATE" WAS ATTEMPTED. THE PUMP WAS INTERROGATED SUCCESSFULLY "ONE MORE TIME" AND CONTINUED TO INDICATE SHELF STATE. WHEN ANOTHER UPDATE WAS ATTEMPTED "TELEMETRY INVALID, REPOSITION HEAD" MESSAGES WERE RECEIVED. TROUBLESHOOTING WAS ATTEMPTED WITHOUT SUCCESS, INCLUDING THE USE OF TWO NEW PROGRAMMERS. THE PT WAS ADMITTED TO THE HOSPITAL AND GIVEN A PT CONTROLLED ANALGESIA FOR PAIN. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 51 YR Hospitalization IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT#N260346014| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER : MODEL 8835, LOT# NPG018257N| EXPLANTED:| CATHETER: MODEL 8596SC, LOT#N251583005| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT#UNK