BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2955535 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02081
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 18, 2012
    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
    OH, 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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2002; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 82% OF EXPECTED LONGEVITY. 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. PRODUCT PERFORMANCE INFORMATION WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THAT BATTERY DEPLETION WAS INDICATED. ELECTIVE REPLACEMENT INDICATOR DATE WAS OBSERVED ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION POSSIBLE DUE TO CHRONIC HIGH THRESHOLDS ON THE RIGHT AND LEFT VENTRICULAR LEADS. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD HAD LOW IMPEDANCE AND A POSSIBLE FRACTURE. THE DEVICE WAS REPLACED. THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD WAS CAPPED AND AN EXISITING LEAD WAS USED. THE HIGH VOLTAGE PORTION OF THE RIGHT VENTRICULAR LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION POSSIBLE DUE TO CHRONIC HIGH THRESHOLDS ON THE RIGHT AND LEFT VENTRICULAR LEADS. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD HAD LOW IMPEDANCE AND A POSSIBLE FRACTURE. THE DEVICE WAS REPLACED. THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD WAS CAPPED AND AN EXISITING LEAD WAS USED. THE HIGH VOLTAGE PORTION OF THE RIGHT VENTRICULAR LEAD REMAINS IN USE. THE LEFT VENTRICULAR LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58754 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD