BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20457926 · Received October 15, 2024

    Report

    Report Number
    3006630150-2024-06990
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 25, 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
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: 18987870 PRODUCT FAMILY: LINEAR ST LEAD KIT 70 CM UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH:5054243 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: 18988041 PRODUCT FAMILY: LINEAR ST LEAD KIT 70 CM UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH:5031565.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: 18987870. PRODUCT FAMILY: LINEAR ST LEAD KIT 70 CM, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 5054243. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: 18988041. PRODUCT FAMILY: LINEAR ST LEAD KIT 70 CM, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 5031565.

    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 WAS RECEIVED THAT THE BOSTON SCIENTIFIC SPINAL CORD STIMULATION (SCS) SYSTEM WAS NOT EXPLANTED BUT WERE IMPLANTED IN THE PATIENT. PATIENT HAD A NON-BOSTON SCIENTIFIC SCS SYSTEM THAT WAS EXPLANTED. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED PER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425019 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 336669 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention