BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 2050696 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01476
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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): ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE HAD ADDITIONAL ANALYSIS PERFORMED TO IDENTIFY THE FAILURE MECHANISM OF THE PREMATURE BATTERY DEPLETION. WHEN POWERED WITH AN EXTERNAL SUPPLY, THE SYSTEM CURRENT DRAIN MEASURED WAS NOMINAL. TELEMETRY AND PACING FUNCTIONED NOMINALLY. THE DEVICE WAS SUBJECTED TO APPROXIMATELY 60°C FOR MORE THAN 17 HOURS. NOMINAL DEVICE SYSTEM CURRENT DRAIN WAS OBSERVED THROUGHOUT THE ANALYSIS. REGULATED SUPPLY AND REFERENCE VOLTAGES WERE NOMINAL. NO ANOMALIES WERE OBSERVED DURING OPTICAL INSPECTION, WHICH INCLUDED THE STACKED CHIP SCALE PACKAGE (SCSP). THE ANALYSIS WAS TERMINATED DUE TO THE INABILITY TO ESTABLISH A HIGH CURRENT DRAIN CONDITION. NO HYBRID ANOMALIES WERE OBSERVED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN EXPRESSED DISSATISFACTION WITH THE DEVICE LONGEVITY AS THE DEVICE REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) PREMATURELY, POSSIBLY DO TO EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD