BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 4161567 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19037
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY CONTINUED: UPON FURTHER ANALYSIS, REVIEW OF PERFORMANCE DATA IDENTIFIED THAT THE DEVICE INCURRED A SINGLE POWER-ON RESET (POR) DURING A FAILED HIGH VOLTAGE (HV) DELIVERY ATTEMPT. THE REASON CODE LISTED IN THE DEVICE INTERNAL MEMORY WAS ¿NO REASON¿. REPEATED ATTEMPTS TO INDUCE THE NO REASON CODE POR WERE UNSUCCESSFUL DURING ANALYSIS. EXAMINATION OF THE DEVICE NOTED A MARK ON THE BACKSIDE OF THE DEVICE. NO EVIDENCE OF INTERNAL ARCING WAS FOUND. THE PERIMETER OF THE STACKED CHIP SCALE PACKAGE (SCSP) COMPONENT WAS OPTICALLY INSPECTED. NO ANOMALIES WERE OBSERVED. THE ANALYSIS WAS TERMINATED DUE TO AN INABILITY TO REPRODUCE THE RESET EXPERIENCED IN THE FIELD. NO HYBRID ANOMALIES WERE OBSERVED THAT WOULD ACCOUNT FOR THE FIELD-RECORDED ELECTRICAL RESET.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. THE RETURNED DEVICE INDICATED A FIRMWARE ERROR MESSAGE/CODE. CONCOMITANT PRODUCT: PRODUCT ID 693565, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, TESTED OUT OF SPECIFICATION AND IS BEING REPORTED BASED ON ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641846 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5076-52 LEAD