BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 7675697 · Received July 10, 2018

    Report

    Report Number
    3006630150-2018-60086
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 6, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ONE OF THE PATIENTS LEADS FROM THE PADDLE WOULD NOT PLUGGED INTO THE NEW IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPLACED AND THE OTHER TWO LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. MODEL NUMBER/CATALOG NUMBER: SC-2135-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER : N/A; MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 50 CM. 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 MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENTS IPG REPLACEMENT PROCEDURE (MFR REPORT #: 3006630150-2018-01008), THE PHYSICIAN COULD ONLY CONNECT ONE OF THE THREE LEADS TO THE IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE OTHER TWO LEADS WILL BE CONNECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENTS IPG REPLACEMENT PROCEDURE (MFR REPORT #: 3006630150-2018-01008), THE PHYSICIAN COULD ONLY CONNECT ONE OF THE THREE LEADS TO THE IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE OTHER TWO LEADS WILL BE CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515999 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8116-50 112576

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention