BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15193383 · Received August 9, 2022

    Report

    Report Number
    3006630150-2022-03928
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    May 4, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI; UPN: M365SC2408740; MODEL: SC-2408-74 (4); SERIAL: (B)(4); LOT: 5123426, 5031582, 7073974, 7073975.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74 (4), SERIAL: (B)(6), LOT: 5123426, 5031582, 7073974, 7073975.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THEREFORE, UNDERWENT A SPINAL CORD STIMULATOR SYSTEM EXPLANT PROCEDURE. THE INFECTION HAS IMPROVED POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION REGARDING THE INFECTION HAS BEEN UNABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THEREFORE, UNDERWENT A SPINAL CORD STIMULATOR SYSTEM EXPLANT PROCEDURE. THE INFECTION HAS IMPROVED POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION REGARDING THE INFECTION HAS BEEN UNABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WAS LOCATED AT THE IPG AND LEAD SITE. THE SYMPTOMS OF THE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION WERE FEVER, REDNESS, HYPOTENSION AND SEPSIS. THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTICS. THE INFECTION WAS SUSPECTED TO BE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942509 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 528615 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other| R