BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 6161590 · Received December 9, 2016

    Report

    Report Number
    3004209178-2016-25766
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 90% 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED SUSPECTED PREMATURE BATTERY DEPLETION AND THE LEFT VENTRICULAR (LV) LEAD SHOWED LOW PACING IMPEDANCE, ALONG WITH A HIGH LV PACING THRESHOLD. IT WAS NOTED THE LV LEAD WAS OBSERVED TO BE IN THE PERICARDIAL SPACE, WHICH WAS THE PROBABLE CAUSE FOR THE LOW IMPEDANCE AND HIGH THRESHOLD. THE CRT-D AND LV LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811309 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D204TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 5076-52 LEAD, 6947M62 LEAD, 4296-88 LEAD