BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 18196725 · Received November 22, 2023

    Report

    Report Number
    3006630150-2023-07295
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 26, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7071888 / 7073852; PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 29661765.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BRUISING AND PAIN AT THE BATTERY SITE AND FEELING DISCOMFORT. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS TOO SHALLOW DUE TO MIGRATION. IT WAS ALSO MENTIONED THAT DURING THE PROCEDURE THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SYSTEM REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED AS IT WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041911 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 205239 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention