BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22699349 · Received August 4, 2025

    Report

    Report Number
    3006630150-2025-06123
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    February 10, 2025
    Report Date
    August 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9208150 MODEL: SC-9208-15 SERIAL: (B)(6) BATCH: (B)(6) UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(6), BATCH: 7070805, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCS PATIENT UNDERWENT A SYSTEM REVISION PROCEDURE DUE TO HIGH IMPEDANCES ON NON BOSTON SCIENTIFIC LEADS, WHICH WERE CAUSING INADEQUATE COVERAGE OF PAIN AREAS AND PREVENTING THERAPEUTIC BENEFIT FROM THE STIMULATOR. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED DUE TO CHARGING DIFFICULTIES, AND THE ADAPTERS WERE REMOVED AS THEY WERE NO LONGER NEEDED IN THE NEWLY IMPLANTED SYSTEM. ELECTROCAUTERY WAS USED TO PERFORM THE EXPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCATION OF THE EXPLANTED DEVICES REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782541 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 517245 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention