BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16873515 · Received May 4, 2023

    Report

    Report Number
    3006630150-2023-02514
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    March 9, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6). BATCH: 5072733 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6). BATCH: 7071560 PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150 MODEL: SC-9218-15 SERIAL: (B)(6). BATCH: 7034097 PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150 MODEL: SC-9218-15 SERIAL: (B)(6)BATCH: 7072000.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, IMPLANTED FOR PERIPHERAL NERVE STIMULATION, WAS EXPERIENCING INADEQUATE STIMULATION. THE SYSTEM WAS REPROGRAMMED BUT THE ISSUE REMAINED. THE PHYSICIAN BELIEVED THAT THE PATIENT WAS EXPERIENCING MUSCULAR PAIN NOT NERVOUS SYSTEM PAIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING FINE POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692230 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 518063 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention