BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA VR

    MDR report key: 2954791 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02470
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING DISCRIMINATORS DID NOT WITH-HOLD THERAPY AND THAT A LEAD INTEGRITY ALERT TRIGGERED FOR OVERSENSING. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58300 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Life Threatening 6935 IMPLANTABLE TACHY LEAD