BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231117 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06900
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN APRIL THAT THE PT WAS GOING THROUGH WITHDRAWAL. IT WAS LATER REPORTED IN AUGUST THAT AN ALARM WAS NOT HEARD, BUT WAS CONFIRMED BY TELEMETRY. THE PT WAS TRAVELLING APPROX 6 MONTHS BEFORE THE EVENT WAS REPORTED, DID NOT HEAR THE ALARM, MISSED THE REFILL, AND SUBSEQUENTLY WENT INTO WITHDRAWAL. WHEN THE PT WENT TO THE CLINIC "THEY COULD NOT GET THE ALARM TO WORK." THIS HAPPENED AGAIN A MONTH BEFORE THE EVENT WAS REPORTED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS HYDROMORPHONE. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 55 YR Other IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N133393006| EXPLANTED: