BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1192082 · Received October 7, 2008

    Report

    Report Number
    2182207-2008-06402
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY WAS NOTED. THE EXPECTED RESERVOIR VOLUME WAS 4.9 ML, ACTUAL RESERVOIR VOLUME WAS 20 ML. THE PATIENT HAS BEEN REFERRED TO A SURGEON AND THE PUMP MAY BE EXPLANTED. PER THE REPORTER, THIS IS THE SECOND PUMP FOR THIS PATIENT THAT WAS "DEFECTIVE." NO PATIENT SYMPTOMS WERE REPORTED. THE PUMP CONTAINED MORPHINE (PF MORPHINE SULFATE). THE SPECIFIC DEVICE INFORMATION WAS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8711 LOT# N104536002| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED