BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24616147 · Received March 17, 2026

    Report

    Report Number
    3006630150-2026-01556
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 9, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7082933 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7082477 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM 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) LEADS WERE REPLACED DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108164 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 582983 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention