BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18022790 · Received October 27, 2023

    Report

    Report Number
    3006630150-2023-06594
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 5124960 / 5137609. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5090347 / 5114336.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AS THE IPG WAS VISIBLY STICKING OUT. NO SKIN BREAKAGE. THE PATIENT UNDERWENT FULL SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURN AS PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154978 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 351116 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention