BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24989674 · Received April 24, 2026

    Report

    Report Number
    3006630150-2026-02613
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2021. BLOCK D6B: EXPLANT DATE: 2021 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8336-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7072049, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO INFECTION. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600352 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 530163 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention