BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2250733 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07705
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 THERE WAS A VOLUME DISCREPANCY PROBLEM, THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THE RPTR DID NOT PROVIDE SPECIFIC VALUES FOR VOLUMES. A DYE STUDY WAS SCHEDULED TO BE PERFORMED. IT WAS LATER REPORTED THAT THE SURGEON REPLACED THE SUTURELESS CONNECTOR WHICH HE FELT HAD A PIN HOLE LEAK. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED.

    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 Required Intervention