BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14399495 · Received May 13, 2022

    Report

    Report Number
    3006630150-2022-02221
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    April 25, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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: M365SC2317500; MODEL: SC-2317-50; SERIAL: (B)(4); BATCH: 7073134/7072095.

    Additional Manufacturer Narrative · 0

    SC-1232 SN: (B)(6). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A LABELING REVIEW FOUND THAT PAIN AT THE POCKET SITE IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. SC-2317-50 SN: (B)(6). THE RETURNED LEADS WERE ANALYZED AND THEY WERE CLEANLY CUT DURING THE EXPLANT PROCEDURE. THE DISTAL PORTION, ABOUT 26 CENTIMETERS, WERE NOT RETURNED. ASIDE FROM THE CLEAN CUT DAMAGE, VISUAL AND X-RAY INSPECTIONS CONFIRMED NO OTHER ANOMALIES ON THE LEADS. THE DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED A FAILURE. THE SOURCE OF THE PAIN WAS NOT DETERMINED. HOWEVER, A LABELING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EXTREME PAIN AT THE POCKET SITE AND WAS ADMITTED IN THE EMERGENCY ROOM FOR TWO DAYS. THE PAIN STILL PERSISTED AFTER THE DEVICE WAS TURNED OFF AND PROGRAMS WERE DELETED. THE PHYSICIAN INDICATED THAT IT WAS NOT DEVICE RELATED, HOWEVER, THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EXTREME PAIN AT THE POCKET SITE AND WAS ADMITTED IN THE EMERGENCY ROOM FOR TWO DAYS. THE PAIN STILL PERSISTED AFTER THE DEVICE WAS TURNED OFF AND PROGRAMS WERE DELETED. THE PHYSICIAN INDICATED THAT IT WAS NOT DEVICE RELATED, HOWEVER, THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691858 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 519464 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention