BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24616569 · Received March 17, 2026

    Report

    Report Number
    3006630150-2026-01558
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    January 1, 2022
    Report Date
    March 17, 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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED IN 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8336-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7072315. 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 PROCEDURE WHEREIN THE IPG AND SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WERE EXPLANTED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678919 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 536188 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention