BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST

    MDR report key: 3992791 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14765
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1249-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN THE BATTERY.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) AND AT THE TIME OF GENERATOR REPLACEMENT THE DEVICE WAS AT A DEPLETED CONDITION WITH NO TELEMETRY. IT WAS NOTED THAT THE DEVICE WAS AT NORMAL ERI BUT DEFERRED REPLACEMENT FOR AN EXTENDED TIME. THE DEVICE WAS EXPLANTED 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
    469053 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 694765 LEAD