BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790679 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15358
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    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) THE DEVICE WAS RETURNED AND ANALYZED. THE LOW PACING OUTPUT AND LOW LEAD IMPEDANCE MEASUREMENTS REPORTED BY THE SUBMITTER WERE CONFIRMED. THE CAN WAS OPENED. LOW MAGNITUDE NVDD VALUES WERE NOTED. SHORTLY AFTER THE CAN OPENING, THE SYMPTOMS WERE OBSERVED TO CLEAR OVER A PERIOD OF ABOUT 20 MINUTES. A SIMILAR NVDD FAILURE WAS ABLE TO BE INTRODUCED BY PLACING THE DEVICE IN 85% HUMIDITY. HOWEVER, THE LEAD IMPEDANCE FAILURE REMAINED CLEARED. NO ROOT CAUSE FOR THE NVDD FAILURE WAS IDENTIFIED. (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE PROGRAMMER SAVE TO DISK DATA FILE (B)(4) SHOWS ONE ALERT EVENT FOR "ATRIAL BIPOLAR LEAD IMPEDANCE 114 OHMS", AND ONE ALERT EVENT FOR "RIGHT VENTRICULAR BIPOLAR LEAD IMPEDANCE 114 OHMS" ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES ON BOTH THE ATRIAL AND VENTRICULAR LEADS WERE DROPPING. THE VENTRICULAR LEAD ALSO HAD OVERSENSING AND NO CAPTURE. THE LEADS WERE REMOVED FROM THE DEVICE AND TESTED NORMAL, BOTH PINS WERE ACROSS THE HEADER AND ONLY NOISE WAS SEEN ON THE LEADS. THE DEVICE HAD NO PACING OUTPUT AND SENSING DIFFICULTY; LEAD IMPEDANCES AND SENSING OUT OF RANGE WHEN PLUGGED IN HEADER BUT THE LEADS FUNCTIONING APPROPRIATELY OUT OF HEADER. THE ATRIAL LEAD REMAINS IN USE. THE VENTRICULAR LEAD WAS CAPPED DUE TO MEDICAL JUDGMENT AND 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 IMPEDANCES ON BOTH THE ATRIAL AND VENTRICULAR LEADS WERE DROPPING. THE VENTRICULAR LEAD ALSO HAD OVERSENSING AND NO CAPTURE. THE LEADS WERE REMOVED FROM THE DEVICE AND TESTED NORMAL, BOTH PINS WERE ACROSS THE HEADER AND ONLY NOISE WAS SEEN ON THE LEADS. THE DEVICE HAD NO PACING OUTPUT AND SENSING DIFFICULTY; LEAD IMPEDANCES AND SENSING OUT OF RANGE WHEN PLUGGED IN HEADER BUT THE LEADS FUNCTIONING APPROPRIATELY OUT OF HEADER. THE ATRIAL LEAD REMAINS IN USE. THE VENTRICULAR LEAD WAS CAPPED DUE TO MEDICAL JUDGMENT AND 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 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R