BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21108163 · Received January 8, 2025

    Report

    Report Number
    3006630150-2024-09352
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 8, 2025
    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
    FL, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5113522/ 5110865.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) CERVICAL LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPLACED WITH A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE DEVICE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT BOTH CERVICAL LEADS WERE FRAYED AND WIRE EXPOSED ON ENTRY TO PORTS. PIECES OF THE LEADS WERE COMING OFF ON PHYSICIANS FINGER. THE PHYSICIAN DECIDED TO CLIP THE CERVICAL LEADS AND ABANDON THEM IN THE POCKET OF THE IPG. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387240 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 354060 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention