BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20054251 · Received August 23, 2024

    Report

    Report Number
    3006630150-2024-05554
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 31, 2022
    Report Date
    August 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED YEARS AGO FROM DATE MANUFACTURER WAS MADE AWARE. BLOCK D6B: EXPLANT DATE: 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: 5061065/5061233. PRODUCT/FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 22064391.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL SPINAL CORD STIMULATOR SYSTEM EXPLANT PROCEDURE AS IT WAS CAUSING MORE PAIN. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363692 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 336312 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention