BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 7257844 · Received February 8, 2018

    Report

    Report Number
    3004209178-2018-02873
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    November 7, 2017
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. HYBRID ANALYSIS CONFIRMED THE REPORTED FAILURE WAS DUE TO A SEVERELY DEPLETED BATTERY. WHEN POWERED BY AN EXTERNAL SUPPLY, THE SYSTEM CURRENT DRAIN WAS NOMINAL, AND THE DEVICE WAS FULLY FUNCTIONAL THROUGHOUT THE ANALYSIS. NO BATTERY DEPLETION MECHANISM, SUCH AS HIGH SYSTEM CURRENT DRAIN, WAS OBSERVED. NO HYBRID ANOMALIES WERE FOUND. BATTERY ANALYSIS REVEALED THAT NO INTERNAL SHORT IN THE BATTERY WAS FOUND. BACK-LIT IMAGES SHOWED UNIFORM LITHIUM UTILIZATION ACROSS THE ANODE. A REVIEW OF THE MANUFACTURING DATA FOUND NO ANOMALIES NOR IRREGULARITIES NOTED DURING THE MANUFACTURING OF THIS CELL AND THE BATTERY PASSED ALL INSPECTIONS AND ELECTRICAL TESTING. RESULTS OF THE BATTERY ANALYSIS FOUND NO EVIDENCE OF INTERNAL SHORTING OR OTHER ISSUES RELATED TO BATTERY PERFORMANCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEART RATE WAS "IN THE 20S" AND IT WAS NOTED THE DEVICE MAY HAVE BEEN PROGRAMMED OFF DUE TO A "LEAD ISSUE." FOLLOW-UP WITH THE PHYSICIAN'S OFFICE WAS ATTEMPTED BUT NO INFORMATION COULD BE OBTAINED. THE DEVICE REGISTRY SYSTEM SHOWS THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND DOWNGRADED WITH A DUAL-CHAMBER IMPLANTABLE PULSE GENERATOR (IPG), AND THE LEFT VENTRICULAR LEAD WAS CAPPED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95414 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R (B)(4) LEAD, (B)(4) LEAD, (B)(4) LEAD