BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2953653 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02029
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 19, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5072 IMPLANTABLE PACING LEAD: (B)(6) 2006. 6949 IMPLANTABLE TACHY LEAD: 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE DEVICE WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE ANALYST COMMENTED THAT ON 2012 (B)(4) THE BATTERY VOLTAGE WAS 2.61V AND HAD NOT YET REACHED THE ERI TRIGGER.

    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 EXPERIENCED MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSING IN THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER REPORTED THAT THE RV LEAD WAS FRACTURED AND HIGH LEAD IMPEDANCE WAS OBSERVED. THERE WAS ALSO POSSIBLE EARLY DEVICE BATTERY DEPLETION REPORTED DUE TO THE MULTIPLE SHOCKS DELIVERED. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND THE CHRONIC LEFT VENTRICULAR PACING LEAD HAS BEEN CONNECTED TO THE RV PACING PORT OF THE DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSSIBLE EARLY DEVICE BATTERY DEPLETION DUE TO MULTIPLE INAPPROPRIATE SHOCKS DELIVERED. THE DEVICE WAS INACTIVATED AND NO FURTHER INTERVENTION IS PLANNED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57029 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 00079 YR Hospitalization| L| R 4548 COMPETITOR IMPLANTABLE PACING LEAD