BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19240313 · Received May 3, 2024

    Report

    Report Number
    3006630150-2024-02824
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    February 20, 2021
    Report Date
    May 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI; UPN: M365SC2408740; MODEL: SC-2408-74; SERIAL/ BATCH: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI; UPN: M365SC2408740; MODEL: SC-2408-74; SERIAL/ BATCH: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI; UPN: M365SC2408740; MODEL: SC-2408-74; SERIAL/ BATCH: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI; UPN: M365SC2408740; MODEL: SC-2408-74; SERIAL/ BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A LOSS OF PAIN RELIEF FROM THE IMPLANTED SCS SYSTEM. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE FULL SYSTEM WAS EXPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99172 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 357205 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention