BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 23030441 · Received September 11, 2025

    Report

    Report Number
    3006630150-2025-07492
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    June 10, 2021
    Report Date
    November 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7091308/7090289. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED, THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED, THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644111 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 202438 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention