BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18722861 · Received February 16, 2024

    Report

    Report Number
    3006630150-2024-00743
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    January 23, 2023
    Report Date
    February 16, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 5089942 / 5090111 UPN: M365SC2218500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 20577608 / 20577608

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE KEEPING THE DEVICE ON. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND ALL EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425052 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 340590 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention