BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 13058399 · Received December 22, 2021

    Report

    Report Number
    3006630150-2021-07172
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 19, 2021
    Report Date
    January 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: ST LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7080802/7080807.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED. THE PATIENT WAS PLACED ON HIGH DOSE OF ANTIBIOTIC AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEADS WERE SENT FOR CULTURE AND WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PATIENT UNDERWENT AN PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED. THE WAS PLACED ON HIGH DOSE OF ANTIBIOTIC AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEADS WERE SENT FOR CULTURE AND WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. CULTURE WERE TAKEN AND THE RESULTS ARE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966449 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 522534 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention