BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 22206749 · Received June 13, 2025

    Report

    Report Number
    3006630150-2025-04431
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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-LINEAR LEADS, UPN: M365SC2317700,MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5101160, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5158715, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H6. 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-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 5101160 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 5158715 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT NEEDS TO CHARGE THE IMPLANTABLE PULSE GENERATOR (IPG) MORE OFTEN. IT WAS NOTED THAT PATIENT ALSO EXPERIENCED SHOCKING SENSATION AND IMPEDANCES WERE FOUND ON PATIENTS SPINAL CORD STIMULATOR LEAD. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS NOT RELEASED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT NEEDS TO CHARGE THE IMPLANTABLE PULSE GENERATOR (IPG) MORE OFTEN. IT WAS NOTED THAT PATIENT ALSO EXPERIENCED SHOCKING SENSATION AND IMPEDANCES WERE FOUND ON PATIENTS SPINAL CORD STIMULATOR LEAD. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619311 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 359334 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1