BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21415255 · Received February 19, 2025

    Report

    Report Number
    3006630150-2025-00855
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    March 26, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50 SERIAL: (B)(6), BATCH: 5081973/5081138.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED. ADDITIONALLY, THE PATIENT STATED THAT THE LEADS HAD COME OUT OF THEIR BACK, WITH ONE LEAD FLOATING IN THE BODY AND THE OTHER WRAPPED AROUND THE SPINE. ALL DEVICE COMPONENTS WERE EXPLANTED. NO DEVICE MALFUNCTION WAS SUSPECTED. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170953 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 342269 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention