BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19056760 · Received April 6, 2024

    Report

    Report Number
    3006630150-2024-02139
    Event Type
    Injury
    Date Received
    April 6, 2024
    Date of Event
    March 12, 2024
    Report Date
    August 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1232 SN: (B)(6). THE RETURNED IPG WAS ANALYZED AND WOULD NOT CHARGE DESPITE MULTIPLE ATTEMPTS. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS CONFIRMED. THE INVESTIGATION REVEALED THAT THERE WAS A CIRCUIT DAMAGE. TYPICALLY, THIS TYPE OF DAMAGE IS CAUSED BY AN EXTERNAL HIGH VOLTAGE OR HIGH CURRENT TRANSIENT SOURCES. THE PROBABLE CAUSE IS DUE TO UNINTENDED USE ERROR WHICH CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(6), BATCH: 7073120.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE PATIENTS PREVIOUS REVISION PROCEDURE (MFR 3006630150-2024-02136) THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTICED THAT THE IPG WAS NOT WORKING AS INTENDED. IT WAS REVEALED THROUGH XRAY THAT THE PATIENTS LEAD HAD MIGRATED AND THAT A HEAVY SCAR TISSUE WAS IMPEDING THE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED, AND THE LEAD WAS REVISED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE PATIENTS PREVIOUS REVISION PROCEDURE (MFR 3006630150-2024-02136) THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTICED THAT THE IPG WAS NOT WORKING AS INTENDED. IT WAS REVEALED THROUGH XRAY THAT THE PATIENTS LEAD HAD MIGRATED AND THAT A HEAVY SCAR TISSUE WAS IMPEDING THE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED, AND THE LEAD WAS REVISED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084244 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 565133 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention