BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21678706 · Received March 24, 2025

    Report

    Report Number
    3006630150-2025-01800
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 22, 2023
    Report Date
    March 24, 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
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7070554/7074396. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: NA. BATCH: 25949862.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND THERE WAS SOME PROTUBERANCE IN THAT AREA. THE PATIENT ALSO EXPERIENCED A DIFFICULTY CHARGING THE IPG. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482328 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 371777 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention