BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 18328447 · Received December 14, 2023

    Report

    Report Number
    3006630150-2023-07854
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 14, 2023
    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

    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-MRI. UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7072441/7072440.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OPEN WOUND THAT WAS COMPLICATED BY POCKET EROSION. THE PHYSICIAN BELIEVED THAT THE EROSION WAS PROCEDURE OR DEVICE RELATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769168 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 202515 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention