BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2811437 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06314
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE LEAD IMPEDANCE PROBLEM WAS NOT DIRECTLY CONFIRMED. HOWEVER, PACING AMPLITUDES WERE NOTED TO BE LIMITED TO 3.0V TO 4.5V, EVEN WHEN PROGRAMMED TO 8V. WITHIN 2.5 HOURS OF A RESIDUAL GAS ANALYSIS (RGA) TEST, THE PACING OUTPUT WAS CLOSE TO NOMINAL LEVELS, AND WAS A NOMINAL 8V WITHIN LESS THAN 20 HOURS.

    Additional Manufacturer Narrative · 1

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

    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) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. IMPEDANCE - LOW RESISTANCE/IMPEDANCE: 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 03:00:33. PROGRAMMER S2D DATA FILE (B)(4) SHOWS 1- ALERT EVENT FOR "A. BIPOLAR LEAD IMPEDANCE 76 OHMS" ON (B)(4) 2012 03:00:33. IMPEDANCE - IMPEDANCE/RESISTANCE DECREASE: WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN IMPEDANCE DECREASE FOR MIN LVPERM PACE IMPEDANCE = 608 TO 304 OHMS MINIMUM BETWEEN (B)(4) 2012 AND (B)(4) 2012.

    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 PRESENTED TO THE EMERGENCY ROOM DUE TO THE PATIENT ALERT SOUNDING, AND THE DEVICE EXHIBITED VARYING IMPEDANCES WITH ALL LEADS. FURTHER INVESTIGATION DETERMINED THAT THE DEVICE IMPEDANCE CIRCUIT WAS NOT FUNCTIONING PROPERLY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO THE PATIENT ALERT SOUNDING, AND THE DEVICE EXHIBITED VARYING IMPEDANCES WITH ALL LEADS. FURTHER INVESTIGATION DETERMINED THAT THE DEVICE IMPEDANCE CIRCUIT WAS NOT FUNCTIONING PROPERLY. THE DEVICE WAS 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
    1 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 4196 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD