BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2203576 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04103
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 10, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND THERE WAS A POR (POWER ON RESET) WITH NO FIRMWARE ERROR MESSAGE/CODE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WERE 2- POR'S FOR FIRMWARE INITIATED PORS WITH NO REASON CODE, ON (B)(6) 2011 AT 17:21:42 AND 17:21:51. THERE WAS 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 17:21:51.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED THAT NO ANOMALIES WERE FOUND. THERE WAS A RANDOM ACCESS MEMORY (RAM) CHIP MEMORY ERROR. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WERE 2- POR'S FOR FIRMWARE INITIATED PORS WITH NO REASON CODE, ON (B)(6) 2011 AT 17:21:42 AND 17:21:51. THERE WAS 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 17:21:51.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE PERIMETER OF THE STACKED CHIP SCALE PACKAGE (SCSP) COMPONENT WAS PERFORMED. ANALYSIS FOUND THE DEVICE TO BE FUNCTIONAL WITH NO ELECTRICAL FAILURES IDENTIFIED. NO ANOMALIES WERE OBSERVED DURING INSPECTION OF THE PERIMETER OF THE SCSP AFTER REMOVING ALL OF THE SURROUNDING COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO RESCUE THE PATIENT TWICE DURING DEFIBRILLATION THRESHOLD TESTING (DFT) AND AN EXTERNAL DEFIBRILLATION WAS NEEDED. WIRELESS TELEMETRY WAS LOST WHEN ATTEMPTING TO INTERROGATE THE DEVICE. A SECOND ATTEMPT TO INTERROGATE REVEALED THAT WIRELESS TELEMETRY WAS NO LONGER AVAILABLE AND A POWER ON RESET (POR) HAD OCCURRED, LOSING ALL OF THE DFT DATA. THE PATIENT RETURNED TO THE OPERATING ROOM ABOUT A MONTH LATER FOR DEVICE TESTING AND THE WIRELESS TELEMETRY WAS STILL NOT AVAILABLE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 1580 COMPETITOR IMPLANTABLE TACHY LEAD| 1580 COMPETITOR IMPLANTABLE TACHY LEAD| 1488TC COMPETITOR IMPLANTABLE PACING LEAD| 1488TC COMPETITOR IMPLANTABLE PACING LEAD