BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE 8 CONTACT EXTENSION

    MDR report key: 10485961 · Received September 2, 2020

    Report

    Report Number
    3006630150-2020-03858
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 7, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12000, MODEL: DB-1200, SERIAL: (B)(6), BATCH: 21498616. ANALYSIS OF NM-3138-55 SERIAL NUMBER 7022075 REVEALED THROUGH VISUAL INSPECTION THAT THE LEAD WAS CLEANLY CUT. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION CONCLUSION IS THAT THE REPORTED EVENT WAS NOT CONFIRMED AS NO PROBLEM WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL SEVERAL TIMES AND AS A RESULT LOST THERAPY ON ONE SIDE OF THE BODY. HIGH IMPEDANCES WERE OBSERVED. X-RAY RESULTS REVEALED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD ROTATED BY 90 DEGREES. THE PHYSICIAN OPENED THE IPG POCKET SITE AND NOTICED A BROKEN LEAD EXTENSION. THE LEAD EXTENSION WAS REPLACED AND THE IPG REPOSITIONED. ONE IMPEDANCE REMAINS BUT THE STIMULATION IS NOT ACTIVE ON THE CONTACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE IPG ROTATION HAD BEEN NOTICEABLE ON THE X-RAY AND THROUGH THE SKIN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: N/I, UPN: N/I, MODEL: N/I, SERIAL: N/I, BATCH: N/I.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL SEVERAL TIMES AND AS A RESULT LOST THERAPY ON ONE SIDE OF THE BODY. HIGH IMPEDANCES WERE OBSERVED. X-RAY RESULTS REVEALED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD ROTATED BY 90 DEGREES. THE PHYSICIAN OPENED THE IPG POCKET SITE AND NOTICED A BROKEN LEAD EXTENSION. THE LEAD EXTENSION WAS REPLACED AND THE IPG REPOSITIONED. ONE IMPEDANCE REMAINS BUT THE STIMULATION IS NOT ACTIVE ON THE CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950775 VERCISE 8 CONTACT EXTENSION STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7022075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention