BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19048142 · Received April 4, 2024

    Report

    Report Number
    3006630150-2024-02094
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    October 1, 2023
    Report Date
    May 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. D6B: EXPLANT DATE: (B)(6) 2023.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS , UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6) , BATCH: 5075540/5080406.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICE WAS DISCARDED PER HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICE WAS DISCARDED PER HOSPITAL POLICY. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018115 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364575 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention