BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17794022 · Received September 21, 2023

    Report

    Report Number
    3006630150-2023-05743
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 31, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) /(B)(6) . BATCH: 7130813/7116228.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A LARGE AMOUNT OF CLEAR LEAKAGE FROM PATIENTS POCKET SITE. IT WAS NOTED ALSO THAT THERE WAS LEAKAGE GUSHED OUT FROM BOTH INCISIONS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICE WAS REMOVED. THE PATIENT WAS DOING FINE POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS KEPT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519271 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 575792 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention