BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2070161 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03058
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 18, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN FELT THE PT'S PUMP WAS NOT WORKING PROPERLY POST A REPLACEMENT PROCEDURE. THE PT WAS EXPERIENCING AN INCREASE IN MUSCLE TONE/SPASTICITY. A ROTOR STUDY WAS NOT PERFORMED. THE PUMP WAS EXPLANTED AND REPLACED, AND THE PHYSICIAN WAS INQUIRING ON MFR ANALYSIS RESULTS. THE PT HAD RECOVERED FROM THE PROCEDURE WITHOUT SEQUELA. PER TELEMETRY STRIPS, THE DRUG ADMINISTERED VIA THE PUMP WAS COMPOUNDED BACLOFEN WITH A CONCENTRATION OF 4,000.0 MCG/ML. ADD'L INFO WILL BE PROVIDED IN A F/U REPORT AS IT 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 34 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8703W, LOT# L45806| IMPLANTED: