BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16405846 · Received February 20, 2023

    Report

    Report Number
    3006630150-2023-00696
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    January 24, 2023
    Report Date
    February 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7080228; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4) , BATCH: 7078417.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION DURING A SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANT PROCEDURE. THE PATIENTS UNUSUAL ATRIAL FIBRILLATION WAS DETECTED WHEN THE TWO SCS LEADS HAD BEEN IMPLANTED AND THE PATIENT WAS ABOUT TO UNDERGO A SCS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION. THE PATIENTS HEART RATE EXCEEDED 220 BEATS PER MINUTE (BPM). AN ELECTROCARDIOGRAM (ECG) ERROR ALARM ALSO OCCURRED AND THE PATIENTS HEART RATE IMMEDIATELY AFTER SURGERY WAS AROUND 120 BPM. THE PHYSICIAN STATED THAT THERE WAS A POSSIBILITY THAT THE INTRA-OPERATIVE STIMULATION TEST MIGHT HAVE TRIGGERED THE PATIENTS UNUSUAL ATRIAL FIBRILLATION. IT WAS NOTED THAT THERE WERE NO ECF ABNORMALITIES AT THE START OF THE SCS TREATMENT. AS A RESULT, THE PHYSICIAN DECIDED TO DISCONTINUE SCS TREATMENT AND THE ENTIRE SCS SYSTEM WAS REMOVED. THE IMPLANT SURGERY WAS THEN DISCONTINUED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644058 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 534528 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention