BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113743 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03929
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 2, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT'S PUMP SHOWED AN EMPTY RESERVOIR ALARM. IT WAS NOT KNOWN HOW LONG THE PUMP WAS EMPTY, OR IF THE PT MISSED A REFILL. THE MANUFACTURER REP HAD NOT SPOKEN TO DOCTOR AT THE TIME THE EVENT WAS REPORTED AND WAS UNCLEAR OF THE PT'S HISTORY OR SYMPTOMS. THE PUMP LOGS HAD NOT YET CONFIRMED THE DATES OF THE EVENT. THE PUMP WAS INTERROGATED PRIOR TO BEING REVISED. THE PT UNDERWENT PUMP REPLACEMENT SURGERY (DETAILS NOT PROVIDED). THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN 500MCG/ML DELIVERED AT 99MCG/DAY. 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N259865001| IMPLANTED:| EXPLANTED: