BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17700254 · Received September 7, 2023

    Report

    Report Number
    3006630150-2023-05389
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 19, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7129718, 7130068.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT CHARGING OF THE IPG. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES ON HER LEADS. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293830 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 575754 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention