BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18448783 · Received January 4, 2024

    Report

    Report Number
    3006630150-2023-08394
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    August 13, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN AUGUST 2023. BLOCK D6B: AUGUST 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7072251/7073008. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC2218500 MODEL: SC-4318 BATCH: 24748145

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON DURING A NON-DEVICE RELATED BACK SURGERY. THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506057 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 362411 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention