BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18091527 · Received November 8, 2023

    Report

    Report Number
    3006630150-2023-06853
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 17, 2023
    Report Date
    March 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1232 (SN:((B)(6)). THE RETURNED IMPLANTABLE PULSE GENERATOR (IPG) WAS ANALYZED AND DID NOT REVEAL ANY ANOMALIES DURING THE EXTERNAL VISUAL INSPECTION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8436500. MODEL: SC-8436-50. SERIAL: (B)(6). BATCH: 7080434.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A POTENTIAL INFECTION. SYMPTOMS WERE POCKET PAIN AND EXPOSED WIRE IN THE POCKET AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND ALL EXPLANTED COMPONENTS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A POTENTIAL INFECTION. SYMPTOMS WERE POCKET PAIN AND EXPOSED WIRE IN THE POCKET AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND ALL EXPLANTED COMPONENTS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923015 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 568625 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention