BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2183343 · Received July 28, 2011

    Report

    Report Number
    2649622-2011-10912
    Event Type
    Injury
    Date Received
    July 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. IN ADDITION, THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS OBTAINED AND HAVE ANALYZED. THE DATA REVEALED VARYING RESISTANCE/IMPEDANCE. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE AND SPIKE INCREASES FOR MIN AND MAX RV PACE= 480 TO 960 OHMS RANGE BETWEEN (B)(4)-2010 AND (B)(4)-2011. OVERSENSING ALSO WAS DETECTED. THERE WERE THIRTEEN VENTRICULAR NON SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 202 MS AVERAGE V-CYCLE BETWEEN (B)(4)-2011 16:00:52 AND (B)(4)-2011 16:25:46. IN ADDITION, THERE WAS INTERFERENCE/NOISE. THE VENTRICULAR SHORT INTERVAL COUNT SHOWED 18.1 COUNTS AVG/DAY IN 40.96 DAYS, BETWEEN (B)(4)-2011 15:52:58 AND (B)(4)-2011 14:54:56. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPERIENCING OVERSENSING. THE LEAD WAS CAPPED 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. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5594 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5594 IMPLANTABLE PACING LEAD