BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15996727 · Received December 16, 2022

    Report

    Report Number
    3006630150-2022-07038
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 22, 2022
    Report Date
    March 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    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: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072610; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072445; PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8352700, MODEL: SC-8352-70, SERIAL: (B)(4), BATCH: 7005780.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072610; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072445; PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8352700, MODEL: SC-8352-70, SERIAL: (B)(6), BATCH: 7005780.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND NEW PAIN AT HER SPINAL CORD STIMULATOR (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE DUE TO HER FIBROMYALGIA. THE PATIENT REQUIRED A MRI AND HER CURRENT SCS SYSTEM IS NOT COMPATIBLE. AS A RESULT, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED ITEMS WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND NEW PAIN AT HER SPINAL CORD STIMULATOR (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE DUE TO HER FIBROMYALGIA. THE PATIENT REQUIRED A MRI AND HER CURRENT SCS SYSTEM IS NOT COMPATIBLE. AS A RESULT, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED ITEMS WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570779 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 370236 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention