BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 18837328 · Received March 5, 2024

    Report

    Report Number
    3006630150-2024-01212
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    January 30, 2024
    Report Date
    May 20, 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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7079674/7081169.

    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: 7079674/7081169.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AT IPG SITE DUE TO BATTERY WAS STICKING OUT CAUSING DISCOMFORT. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF AND ALSO MENTIONED THAT PATIENT HAD BURNING AND WARMTH WHEN CHARGING. THE PATIENT WILL UNDERGO EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AT IPG SITE DUE TO BATTERY WAS STICKING OUT CAUSING DISCOMFORT. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF AND ALSO MENTIONED THAT PATIENT HAD BURNING AND WARMTH WHEN CHARGING. THE PATIENT WILL UNDERGO EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75033 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 373535 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1