BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1935934 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10157
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 23, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELL IN JULY. THE PT HAD PAIN OVER THE PUMP AREA; THE PAIN HAD BEEN OCCURRING THE LAST COUPLE MONTHS AND THE PUMP HAD CHANGED POSITIONS. AT THE PUMP REFILL VISIT IN MID-NOVEMBER, THE HEALTHCARE PROVIDER HAD A HARD TIME FINDING THE REFILL PORT AND SAID THE "SIDE PORT WAS DISPLACED." THE PT WAS SCHEDULED TO HAVE A MYELOGRAM AND CT SCAN IN EARLY DECEMBER. IT WS UNK IF THE FALL IN JULY WAS RELATED TO THE PUMP MOVING. IT WAS NOTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT; THE PT ONLY GOT PAIN RELIEF WHEN THEY WERE GIVEN A BOLUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A F/U 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG016784N| EXPLANTED:| CATHETER: MODEL 8711, LOT# N247279004