BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA VR

    MDR report key: 11841918 · Received May 18, 2021

    Report

    Report Number
    2182208-2021-02007
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    September 28, 2020
    Report Date
    May 18, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: INAPPROPRIATE DEFIBRILLATOR SHOCK DUE TO OVERSENSING. WHAT IS THE MECHANISM? INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. 2021. 54-58 DOI.ORG/10.1016/J.IPEJ.2020.09.005. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARTICLE REPORTS A PATIENT WHO EXPERIENCED INAPPROPRIATE THERAPY DUE TO NOISE APPROXIMATELY THREE HOURS POST IMPLANT OF THE ICD. THE IMPEDANCE OF THE SHOCKING COIL WAS WIDELY VARYING. THE NEXT DAY, THE PATIENT WAS TAKEN BACK FOR POCKET RE-EXPLORATION. BEFORE UNSCREWING THE LEADS, GENTLE TRACTION ON THE SHOCKING PORT COULD RELEASE IT EASILY DUE TO A LOOSE SET SCREW. THE SET SCREW WAS PROPERLY TIGHTENED. THE STATUS/DISPOSITION OF THE DEVICE APPEARS TO BE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738602 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. D364VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R 6935 LEAD