BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16615355 · Received March 24, 2023

    Report

    Report Number
    3006630150-2023-01547
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    December 1, 2022
    Report Date
    July 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022 FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7072175/ 7072185.

    Additional Manufacturer Narrative · 0

    SC-1232, (SN: (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE. A REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. 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. THEREFORE, THIS INVESTIGATION WAS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION NEAR AT THE BATTERY SITE. NO CULTURE WAS TAKEN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS PER HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION NEAR AT THE BATTERY SITE. NO CULTURE WAS TAKEN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376460 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 548426 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention