BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 13467820 · Received February 6, 2022

    Report

    Report Number
    3006630150-2022-00381
    Event Type
    Injury
    Date Received
    February 6, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A TURN OF NEW YEAR 2022 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7078951/7081399.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WAS EXPERIENCING PAIN AT THE IPG SITE DUE BATTERY HAD MIGRATED. IT WAS ALSO REPORTED THAT THE LEADS HAD MOVED DOWN SLIGHTLY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND REPOSITION OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489192 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 205531 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Female Required Intervention