BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1230538 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07415
    Event Type
    Injury
    Date Received
    November 13, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE READINGS WERE GREATER THAN 2000 OHMS ON ALL OF THE UNIPOLAR PAIRS. THE PATIENT HAD NOT FALLEN. IMPEDANCE READINGS PRIOR TO NEUROSTIMULATOR (INS) REPLACEMENT WERE UNKNOWN. THE PATIENT UNDERWENT SURGERY AND THE INS/EXTENSION AND EXTENSION/LEAD CONNECTIONS WERE DISASSEMBLED AND CHECKED TO MAKE SURE THEY WERE DRY. HIGH IMPEDANCE CONTINUED TO BE OVER 2000 OHMS ON ALL ELECTRODES EXCEPT #1. X-RAYS OF THE LEAD AND EXTENSION LOOKED INTACT. THE PATIENT CONTINUED TO EXPERIENCE SEVERE TREMOR. 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
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL UNKNOWN| EXPLANTED| RIGHT SIDE SIMULATION SYSTEM| EXPLANTED| EXTENSION MODEL 7482