BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1130971 · Received August 21, 2008

    Report

    Report Number
    2182207-2008-05124
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P9600004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SECTION OF THE CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT EXPERIENCED SYMPTOMS OF WITHDRAWAL; INCREASED TIGHTNESS AND AGITATION. AN X-RAY WAS TAKEN (DATE NOT REPORTED) AND LOOKED "FINE". THE PT WAS SUPPLEMENTED WITH ORAL BACLOFEN FOR HIS INCREASED MUSCLE TIGHTNESS. DURING SURGERY, IT LOOKED LIKE THERE WAS HUMAN TISSUE THAT WAS CAUGHT INSIDE THE SUTURELESS CONNECTOR. THE SURGEON FELT THE HUMAN TISSUE THAT WAS CAUGHT INSIDE WAS PREVENTING THE PT FROM GETTING MEDICATION. THE PROXIMAL SECTION OF THE CATHETER WAS REPLACED. THE PUMP WAS USED TO DELIVER LIORESAL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention EXPLANTED| CATHETER MODEL 8596 LOT # N005277122 IMPLANTED| PROGRAMMER MODEL 8840 LOT # UNK| EXPLANTED| CATHETER MODEL 8598 LOT # N004589032 IMPLANTED