BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15136947 · Received July 31, 2022

    Report

    Report Number
    3006630150-2022-03770
    Event Type
    Injury
    Date Received
    July 31, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS , UPN: (B)(4), MODEL: SC-2218-70 , SERIAL: (B)(4), BATCH: 243537/243539.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE ON ONE LEAD. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED PER HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE ON ONE LEAD. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2941137 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 15683497 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention