BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15230237 · Received August 15, 2022

    Report

    Report Number
    3006630150-2022-04067
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 28, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416700. MODEL: SC-8416-70. SERIAL: (B)(4). BATCH: 7072748.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OPENING AT THE BOTTOM OF IPG AND PADDLE INCISION SITE. NO DRAINAGE WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OPENING AT THE BOTTOM OF IPG AND PADDLE INCISION SITE. NO DRAINAGE WAS NOTED. CULTURES WERE TAKEN AND THE RESULTS WERE NEGATIVE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE AND WAS DOING WELL POSTOEPRATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OPENING AT THE BOTTOM OF IPG AND PADDLE INCISION SITE. NO DRAINAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012842 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 538019 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention