BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 1923091 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06047
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). ONE PATIENT ALERT FOR LOW BATTERY VOLTAGE ALERT WAS RECORDED ON (B)(6) 2010, APPROXIMATELY 13 MONTHS AFTER IMPLANT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). ONE PATIENT ALERT FOR LOW BATTERY VOLTAGE ALERT WAS RECORDED ON (B)(6) 2010, APPROXIMATELY 13 MONTHS AFTER IMPLANT. PRELIMINARY ANALYSIS CONFIRMED THE BATTERY WAS DEPLETED, AND A HIGH CURRENT DRAIN CONDITION WAS NOTED. ANALYSIS OF THE HYBRID IDENTIFIED A CAPACITOR AS THE CAUSE OF THE HIGH CURRENT LEAKAGE. A HOTSPOT INDICATING THE LOCATION OF A DEFECT INSIDE THE CAPACITOR WAS IDENTIFIED WITH THERMAL IMAGING TECHNIQUES. THIS ANALYSIS WAS STOPPED AT THIS POINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEFIBRILLATOR HAD EARLY BATTERY DEPLETION AND A LONG CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEFIBRILLATOR HAD EARLY BATTERY DEPLETION AND A LONG CHARGE 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
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD