BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3052013 · Received April 11, 2013

    Report

    Report Number
    3007566237-2013-01207
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 14, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PHYSICIAN TRIED TO ASPIRATE FROM THE ACCESS PORT WITHOUT SUCCESS. THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR A REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PATIENT¿S FIRST REFILL FOLLOWING IMPLANT IN OCTOBER, A VOLUME DISCREPANCY WAS NOTED. THE ACTUAL RESIDUAL VOLUME (ARV) WAS 39 ML, WHICH WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV). THE LOGS WERE CHECKED AND NO ALARMS WERE NOTED. IT WAS NOTED THAT A DYE STUDY WAS PLANNED. THE PATIENT HAD NOT MENTIONED ANYTHING ABOUT NOT GETTING THERAPY. THE PUMP WAS USED TO DELIVER PRIALT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156539 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention