BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 11945558 · Received June 7, 2021

    Report

    Report Number
    3006630150-2021-02705
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 14, 2021
    Report Date
    July 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET AND LEADS SITE. SYMPTOMS OF DROOPING ARM AND DIFFUSE ALL OVER PAIN WERE NOTED. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE SYMPTOMS AND THEN DISCOVERED AN INFECTION. THE PATIENT WAS DOING WELL.

    Additional Manufacturer Narrative · 1

    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, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 3163153/5146604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET AND LEADS SITE. SYMPTOMS OF DROOPING ARM AND DIFFUSE ALL OVER PAIN WERE NOTED. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE SYMPTOMS AND THEN DISCOVERED AN INFECTION. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845227 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 502966 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention