BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST

    MDR report key: 3992932 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14724
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1248-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE INDICATED A MEMORY ERROR FOR A RAM (RANDOM ACCESS MEMORY) INTEGRATED CIRCUIT. ANALYSIS OF THE DEVICE ALSO REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF A REMOTE MONITORING TRANSMISSION, IT WAS FOUND THAT THE DEVICE EXPERIENCED A CRITICAL RAM (RANDOM ACCESS MEMORY) RESET. ADDITIONAL REVIEW OF DEVICE MEMORY DATA FOUND ANOTHER RESET FROM ABOUT THREE YEARS EARLIER DUE TO PARITY ERROR. WHEN THE DEVICE WAS BEING REPROGRAMMED, LONG CHARGE TIME TRIGGERED EOL (END OF LIFE). 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
    472113 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| R 694765 LEAD