BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19713455 · Received July 10, 2024

    Report

    Report Number
    3006630150-2024-04451
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1232 (SN: (B)(6) THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2218-70 (SN: (B)(6). THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 4 CM FROM THE PROXIMAL END OF THE LEAD AND THE DISTAL PORTION OF THE LEAD WAS NOT RETURNED. THE CLEAN-CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND NOT CONSIDERED A FAILURE. ELECTRICAL TEST COULD NOT BE PERFORMED DUE TO THE CUT LEAD BODY. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT LABELLING 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. THE PROBABLE CAUSE SELECTED IS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL:(B)(6). BATCH: 7083785. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7078252.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE DUE TO INADEQUATE PAIN RELIEF. DURING THE PROCEDURE, THE PHYSICIAN NOTED A SMALL RADIOPAQUE PIECE THAT WAS LEFT BEHIND NEAR THE IPG POCKET. ONE OF THE LEAD IDENTIFIER CONTACTS REMAINED IN THE POCKET AND THE PHYSICIAN WAS UNABLE TO REMOVE IT. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE DUE TO INADEQUATE PAIN RELIEF. DURING THE PROCEDURE, THE PHYSICIAN NOTED A SMALL RADIOPAQUE PIECE THAT WAS LEFT BEHIND NEAR THE IPG POCKET. ONE OF THE LEAD IDENTIFIER CONTACTS REMAINED IN THE POCKET AND THE PHYSICIAN WAS UNABLE TO REMOVE IT. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040700 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 532686 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention