BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2790960 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02274
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    June 21, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RECEIVED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. IT WAS VISUALLY NOTES THAT NO SETSCREW MARKS WERE ON THE PINT. IT APPEARS THA THE LEAD WAS NOT INSERTED FULLY INTO THE HEADER. (B)(4) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE SIX VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 190 MS BETWEEN (B)(4) 2012. THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012. THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAXIMUM VENTRICULAR PACING BIPOLAR IMPEDANCE OF 475 TO 1615 OHMS PEAK BETWEEN (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AFTER HEARING THE PATIENT ALERT TRIGGER. UPON INTERROGATION, TREND DATA INDICATED THAT THE LEAD INTEGRITY ALERT HAD TRIGGERED FOR INCREASING IMPEDANCE TO HIGH MEASUREMENT, OVERSENSING AND NOISE. THE PHYSICIAN OPENED THE POCKET, MANIPULATING THE LEAD, AND CONFIRMED THE NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN WENT TO DISCONNECT THE LEAD AND FOUND THAT THE LEAD EASILY PULLED OUT OF THE DEVICE CONNECTOR BLOCK THE PHYSICIAN DECIDED TO REPLACE BOTH THE RV LEAD AND THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF IT WAS DECIDED TO REPLACE BOTH THE RV LEAD AND THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D264TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5071 IMPLANTABLE PACING LEAD