BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3903459 · Received June 30, 2014

    Report

    Report Number
    3006630150-2014-01480
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD MULTIPLE MAGNETIC RESONANCE IMAGING (MRI) TESTS CAUSING CHARGING ISSUES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT WORKING AND IT APPEARED THAT THE IPG WAS FAULTY. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT WORKING AND IT APPEARED THAT THE IPG WAS FAULTY. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT WORKING AND IT APPEARED THAT THE IPG WAS FAULTY. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379649 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1