BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20501132 · Received October 21, 2024

    Report

    Report Number
    3006630150-2024-07188
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    January 16, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    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 COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7080013. BRAND NAME: LINEAR 3-6 UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7080223.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7080013 AND 7080223. DEVICE ANALYSIS: SC-1232 SN (B)(6): THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2366-50 SN (B)(6): THE RETURNED LEADS WERE ANALYZED AND REVEALED THAT BOTH LEADS WERE CLEANLY CUT INTO TWO PIECES AT THE DISTAL PART OF THE LEAD. THIS CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. ELECTRICAL TESTING COULD NOT BE PERFORMED DUE TO THE CUT LEAD BODY. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTIONS OF THE LEADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY PAIN RELIEF WHILE THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG AND BOTH LEADS WERE EXPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY PAIN RELIEF WHILE THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG AND BOTH LEADS WERE EXPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248626 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 587441 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention