BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19527483 · Received June 13, 2024

    Report

    Report Number
    3006630150-2024-03817
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APRIL 2024.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7083861.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION AT THE IPG SITE. THERE WAS DRAINAGE NOTED AS THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION AT THE IPG SITE. THERE WAS DRAINAGE NOTED AS THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED AS PER PHYSICIANS PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783091 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 585113 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention