BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2952443 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01719
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THAT THE RIGHT VENTRICULAR AND SUPERIOR VENA CAVA COIL IMPEDANCES WERE AT 43 AND 56 OHMS THROUGH THE DEVICE. HOWEVER, WHEN A SHOCK WAS DELIVERED, ZERO JOULES WERE DELIVERED. THE PATIENT HAD TO BE EXTERNALLY RESCUED. IT WAS ALSO REPORTED THAT THERE WAS A DEVICE MALFUNTION. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57802 ENTRUST VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Hospitalization| L| R (B)(4) IMPLANTABLE TACHY LEAD