BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18619765 · Received January 31, 2024

    Report

    Report Number
    3006630150-2024-00387
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    February 10, 2020
    Report Date
    April 25, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7070059; BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7070448; BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7070429; BRAND NAME: LINEAR 3-4, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7070016.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4 UPN: (B)(4) MODEL: SC-2352-70 SERIAL: (B)(6) BATCH: 7070059 BRAND NAME: LINEAR 3-6 UPN: (B)(4) MODEL: SC-2366-50 SERIAL: (B)(6) BATCH: 7070448 BRAND NAME: LINEAR 3-6 UPN: (B)(4) MODEL: SC-2366-50 SERIAL: (B)(6) BATCH: 7070429 BRAND NAME: LINEAR 3-4 UPN: (B)(4) MODEL: SC-2352-70 SERIAL: (B)(6) BATCH: 7070016 THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE LEADS WERE DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT RECEIVED MINIMAL RELIEF FROM THE SCS DEVICE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THERE WERE NO REPORTED COMPLICATIONS POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE SPINAL CORD STIMULATION (SCS) PATIENT RECEIVED MINIMAL RELIEF FROM THE SCS DEVICE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THERE WERE NO REPORTED COMPLICATIONS POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260236 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 362005 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention