BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20911068 · Received December 12, 2024

    Report

    Report Number
    3006630150-2024-08671
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    September 23, 2023
    Report Date
    December 12, 2024
    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
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER A YEAR AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7073515/7073566.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) HAD AN INCREASED CHARGE BURDEN, AND AN INCREASED STIMULATION NEED. IT WAS ALSO NOTED THAT THE RIGHT SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES AND WAS ABLE TO REPROGRAM AROUND IMPEDANCES FOR ALL PAIN AREAS. THE PATIENT UNDERWENT IPG AND LEAD REPLACEMENT PROCEDURE AND DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICES WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155109 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 371977 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention