BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 13539252 · Received February 15, 2022

    Report

    Report Number
    3006630150-2022-00520
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    September 10, 2021
    Report Date
    February 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729989752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE OF THE PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7081694. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7087898.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG, IMPLANTABLE PULSE GENERATOR, SITE AND INTERMEDIATE INCISION SITE. THE SITE WAS OBSERVED TO BE TENDER AND PUFFY WITH POSSIBLE FLUID ACCUMULATION DUE TO THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT OF THEIR ENTIRE SYSTEM AND WAS PLACED ON ANTIBIOTICS FOR FOUR TO SIX WEEKS. THE PHYSICIAN STATED THAT THE INFECTION IS NOT DEVICE RELATED BUT THE CAUSE IS UNKNOWN. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9660 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1408 201402 08714729989752

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention