BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 21537821 · Received March 6, 2025

    Report

    Report Number
    3006630150-2025-01275
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    January 31, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN JANUARY. BLOCK D6B: EXPLANT DATE: JANUARY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416500. MODEL: SC-8416-50. SERIAL: (B)(6). BATCH: 1104347. UDI#: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416500. MODEL: SC-8416-50. SERIAL: (B)(6). BATCH: 7070611. UDI#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATOR (SCS) WAS EXPLANTED DUE TO INADEQUATE PAIN RELIEF. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437732 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 366664 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention