BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19904505 · Received August 5, 2024

    Report

    Report Number
    3006630150-2024-05104
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EVENT DATE UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7070473. BRAND NAME: LINEAR 3-6. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7072988. BRAND NAME: LINEAR 3-6. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7073236.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING WITHOUT ISSUE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274652 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 377988 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention