BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1864452 · Received October 6, 2010

    Report

    Report Number
    3004209178-2010-07667
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LAST TWO REFILLS, THE RESERVOIR VOLUME HAD A 3ML DISCREPANCY, AND THE PT WAS NOT RECEIVING ADEQUATE PAIN RELIEF. THE DEVICE WAS EXPLANTED AND REPLACED. BOTH A DYE STUDY AND A ROTOR STUDY WERE PERFORMED. THE RESULTS OF EACH STUDY WERE "UNREMARKABLE". THE PT RECOVERED W/O SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N144298015| IMPLANTED: