BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20535498 · Received October 25, 2024

    Report

    Report Number
    3006630150-2024-07340
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    May 1, 2023
    Report Date
    November 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 1070876 / 7046375.

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150, MODEL: SC-9218-15 , SERIAL: (B)(6), BATCH: 1070876 / 7046375.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO NEEDING THE ABILITY TO GET AN (MAGNETIC RESONANCE IMAGING) MRI ACCESS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568795 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 348361 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention