BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2189758 · Received August 3, 2011

    Report

    Report Number
    2649622-2011-10945
    Event Type
    Injury
    Date Received
    August 3, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE AND LEAD WERE REMOVED AND REPLACED. THE DEVICE HAD SHOWN MULTIPLE NOISE EPISODES, AND THE LEAD WAS APPARENTLY FRACTURED. ANALYSIS OF THE DEVICE AND LEAD ARE 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING 2 - VENTRICULAR NST=210 MS AVERAGE V-CYCLE ON (B)(4)-2010 18:47:26 AND (B)(4)-2011 19:16:30. VF<=210 MS AVERAGE V-CYCLE BETWEEN (B)(4)-2008 11:29:43 AND (B)(4)-2011 22:03:24. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=72.7 COUNTS AVG/DAY, IN 111.62 DAYS, BETWEEN (B)(4)-2011 19:21:09 AND (B)(4)-2011 10:17:41.

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING 2 - VENTRICULAR NST=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 18:47:26 AND (B)(6) 2011 19:16:30. VF<=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2008 11:29:43 AND (B)(6) 2011 22:03:24. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=72.7 COUNTS AVG/DAY, IN 111.62 DAYS, BETWEEN (B)(6) 2011 19:21:09 AND (B)(6) 2011 10:17:41.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE AND LEAD WERE REMOVED AND REPLACED. THE DEVICE HAD SHOWN MULTIPLE NOISE EPISODES, AND THE LEAD WAS APPARENTLY FRACTURED. 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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): WE RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS OBSERVED. THERE WERE TWO VENTRICULAR NON SUSTAINED TACHYCARDIA EPISODES EQUAL TO 210 MS AVERAGE V-CYCLE ON (B)(6) 2010 18:47:26 AND (B)(6) 2011 19:16:30. VENTRICULAR FIBRILLATION GREATER THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2008 11:29:43 AND (B)(6) 2011 22:03:24. IN ADDITION INTERFERENCE/ NOISE WERE OBSERVED. VENTRICULAR SHORT INTERVAL COUNT WAS EQUAL TO 72.7 COUNTS AVG/DAY, IN 111.62 DAYS, BETWEEN (B)(6) 2011 19:21:09 AND (B)(6) 2011 10:17:41.

    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

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE AND LEAD WERE REMOVED AND REPLACED. THE DEVICE HAD SHOWN MULTIPLE NOISE EPISODES, AND THE LEAD WAS APPARENTLY FRACTURED. 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, THE OUTER TUBING OVERLAY MELTED, THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER TUBING WAS KINKED/BUCKLED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS FLEXED, WITHIN FIVE CENTIMETERS OF THE ANCHORING SLEEVE. (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): WE RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS OBSERVED. THERE WERE TWO VENTRICULAR NON SUSTAINED TACHYCARDIA EPISODES EQUAL TO 210 MS AVERAGE V-CYCLE ON (B)(6) 2010 18:47:26 AND (B)(6) 2011 19:16:30. VENTRICULAR FIBRILLATION GREATER THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2008 11:29:43 AND (B)(6) 2011 22:03:24. IN ADDITION INTERFERENCE/ NOISE WERE OBSERVED. VENTRICULAR SHORT INTERVAL COUNT WAS EQUAL TO 72.7 COUNTS AVG/DAY, IN 111.62 DAYS, BETWEEN (B)(6) 2011 19:21:09 AND (B)(6) 2011 10:17:41.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD ALERT. THE SHORT INTERVAL COUNT IS NOW GREATER THAN 8000 AND THERE IS AN INCREASE IN IMPEDANCE FROM 400'S OHMS TO 600'S OHMS. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    .

    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 18 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB