BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 7172375 · Received January 8, 2018

    Report

    Report Number
    3006630150-2018-00037
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 18, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8120-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL MDR IN FIELD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION COULD BE OBTAINED AT THIS TIME. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS SCS WAS NON-FUNCTIONAL. IT WAS ALSO NOTED THAT IT WAS NEVER USED AND IT WAS BOTHERING THE PATIENT. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS SCS WAS NON-FUNCTIONAL. IT WAS ALSO NOTED THAT IT WAS NEVER USED AND IT WAS BOTHERING THE PATIENT. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS SCS WAS NON-FUNCTIONAL. IT WAS ALSO NOTED THAT IT WAS NEVER USED AND IT WAS BOTHERING THE PATIENT. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15105 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1