BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 11961387 · Received June 8, 2021

    Report

    Report Number
    3006630150-2021-02745
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED AFTER THE DATE OF IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 5149411/7071912 . PRODUCT FAMILY: SCS-EXTENSION. UPN: SC-3138-35. MODEL: SC-3138-35. SERIAL: (B)(4). BATCH: 7073635/7073710.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE SPECIFICALLY AT THE BASE OF SKULL WHERE LEADS WERE LOCATED AND THE SITE WHERE EXTENSIONS WERE CONNECTED TO THE LEADS. SYMPTOMS OF INFECTION WERE REDNESS, PUS AND SWELLING. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852289 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 507075 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention