BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2211911 · Received August 10, 2011

    Report

    Report Number
    3007566237-2011-06222
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 28, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THE ACTUAL RESIDUAL VOLUME WAS 3ML, THE EXPECTED RESIDUAL VOLUME WAS 20ML. A CAP DYE STUDY WAS PERFORMED AND THE RESULTS WERE NEGATIVE. THE PT WAS NOT HAVING THERAPY ISSUES. IT WAS LATER REPORTED THAT THERE WAS A DYE STUDY AND ROLLER STUDY PERFORMED AND BOTH APPEARED NORMAL. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. 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 MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention