BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2371386 · Received December 14, 2011

    Report

    Report Number
    2182208-2011-03083
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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: 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. PROGRAMMER DATA SHOWS TWO LEAD INTEGRITY ALERTS ON (B)(6) 2011. TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2011. FIFTEEN VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES OF <=210 MS OCCURRED BETWEEN (B)(6) 2011. THIRTEEN VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES OF <=210 MS OCCURRED BETWEEN (B)(6) 2011. ONE VENTRICULAR FIBRILLATION EPISODE OF 160 MS AVERAGE VENTRICULAR CYCLE OCCURRED ON (B)(6) 2011 11:15:51. TWO VENTRICULAR FIBRILLATION EPISODES OF 1800 MS AVERAGE VENTRICULAR CYCLE OCCURRED ON (B)(6) 2009 AND (B)(6) 2011. VENTRICULAR SHORT INTERVAL COUNT V-SIC=5.8 COUNTS AVG/DAY, IN 95.22 DAYS, BETWEEN (B)(6) 2011. VENTRICULAR SHORT INTERVAL COUNT V-SIC=8.3 COUNTS AVG/DAY, IN 74.19 DAYS, BETWEEN (B)(6) 2011.

    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. ONE LEAD INTEGRITY ALERT OCCURRED ON (B)(6) 2011 11:15:56. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2011 11:15:56. 15 VENTRICULAR NONSUSTAINED TACHYCARDIA (NST) EPISODES OF <=210 MS OCCURRED BETWEEN (B)(6) 2011 11:31:10 AND (B)(6) 2011 12:08:44. ONE VENTRICULAR FIBRILLATION EPISODE OF 160 MS AVERAGE V-CYCLE OCCURRED ON (B)(4) 2011 11:15:51. VENTRICULAR SHORT INTERVAL COUNT V-SIC=5.8 COUNTS AVG/DAY, IN 95.22 DAYS, BETWEEN (B)(4) 2011 10:04:31 AND (B)(4) 2011 15:22:40.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH PROFESSIONAL QUESTIONED WHY AN ALERT TRIGGERED FOR IMPEDANCE NOT TAKEN ON THE SUPERIOR VENA CAVA (SVC) LEAD WHEN THERE IS NO SVC LEAD. IT WAS DETERMINED THAT THIS WAS NOT THE ACTUAL CAUSE FOR THE ALERT. THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE LEAD IS STILL IN USE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD