BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2864949 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11417
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. CONCOMITANT PRODUCTS: 4574 IMPLANTABLE PACING LEAD 2008 (B)(6); 4194 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. DATA FROM THE DEVICE WAS ALSO COLLECTED AND ANALYZED. ANALYSIS OF THE DATA REVEALED THAT THERE WAS A LOW BATTERY VOLTAGE ALERT. TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN THE SAVE TO DISK WAS ON (B)(6) 2012. THE DEVICE RRT WAS LESS THAN OR EQUAL TO 2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BATTERY EQUALING 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHNG ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD