BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2791383 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05346
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED A HYBRID FAILURE THAT DISAPPEARED DURING ANALYSIS. THE LEAD IMPEDANCE FAILURE REPORTED BY THE SUBMITTER WAS CONFIRMED. COLLAPSED NEGATIVE SUPPLIES WERE NOTED AS WELL. HOWEVER THE LEAD IMPEDANCE FAILURE CLEARED AND SUBSEQUENTLY THE NEGATIVE SUPPLIES FAILURES CLEARED AS WELL. VARIOUS ATTEMPTS WERE MADE TO REINTRODUCE THE LEAD IMPEDANCE AND NEGATIVE SUPPLY FAILURES, BUT NONE WERE SUCCESSFUL. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS LOW RESISTANCE/IMPEDANCE WITH A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010. PROGRAMMER SAVE TO DISK DATA FILE (B)(4) SHOWSALERT EVENTS FOR "A BIPOLAR LEAD IMPEDANCE 76 OHMS", "RV BIPOLAR LEAD IMPEDANCE 76 OHMS" AND "LVRING TO RVCOIL LEAD IMPEDANCE 171 OHMS" ON (B)(6) 2012 AT 09:00:27. ALSO, THERE WAS LOW RESISTANCE/IMPEDANCE WITH A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010. PROGRAMMER SAVE TO DISK DATA FILE (B)(4) SHOWSALERT EVENTS FOR "RV BIPOLAR LEAD IMPEDANCE 19 OHMS" AND "LVRING TO LVRING LEAD IMPEDANCE 133 OHMS" ON (B)(6) 2012 AT 09:00:24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN FIVE MONTHS POST IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO A PATIENT ALERT FROM THE DEVICE. THE IMPEDANCE FOR THE LEFT VENTRICULAR, RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS WERE HIGHLY VARIABLE AND LESS THAN 150 OHMS. IT WAS INDICATED THE "PACING IMPEDANCE DROPPED TO NOTHING ON ALL THREE LEADS" AT THE SAME TIME. ALSO THE PATIENT WAS HAVING PREMATURE VENTRICULAR CONTRACTIONS WHICH THE DEVICE COMPLETELY UNDERSENSED. THERE WAS ALSO NO ELECTROGRAMS THROUGH THE DEVICE. DURING THE REVISION PROCEDURE, IT WAS FOUND THAT ALL THREE LEADS TESTED OKAY ONCE DISCONNECTED FROM THE DEVICE. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 7122 COMPETITOR IMPLANTABLE TACHY LEAD| 5068 IMPLANTABLE PACING LEAD| 4296 IMPLANTABLE PACING LEAD