BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 21702481 · Received March 26, 2025

    Report

    Report Number
    3006630150-2025-01923
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500 MODEL: SC-8216-50 SERIAL: (B)(6) BATCH: 7071177.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT AND SPINAL CORD STIMULATION (SCS) LEAD REVISION PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS REPLACED FOR A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE DEVICE. THE INITIAL PLAN FOR THE LEAD WAS TO REMOVE IT AS THE PATIENT DID NOT LIKE ITS POSITION. THE PHYSICIAN REALIZED THAT IT WAS TOO DIFFICULT AND OPTED TO PLUG ALL LEAD TAILS IN THE IPG THEN FINISHED THE CASE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT AND SPINAL CORD STIMULATION (SCS) LEAD REVISION PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001285 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 371809 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention