BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1861768 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10104
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED NO ANOMALIES IN IMPEDANCE; IMPEDANCE MEASUREMENTS NOT RECORDED AS DEVICE WAS NOT ACTIVATED LONG ENOUGH. ANALYSIS REVEALED "INTERFERENCE/NOISE: (B)(4).

    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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED NO ANOMALIES IN IMPEDANCE; IMPEDANCE MEASUREMENTS NOT RECORDED AS DEVICE WAS NOT ACTIVATED LONG ENOUGH. ANALYSIS REVEALED "INTERFERENCE/NOISE: 34 V-SIC RECORDED IN 8 HOURS SINCE LAST SESSION, AVERAGE OF 96/DAY", "OVERSENSING: 5 SHORT V-V CYCLES (<220MS PERIOD) NOTED ON (B)(6) 2010" AND LEAD INTEGRITY ALERT TRIGGERED: LEAD INTEGRITY ALERT TRIGGERED BASED ON SIC AND SHORT V-V CYCLES. PATIENT ALERT SOUNDED (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    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 DURING IMPLANT OF A NEW DEVICE THERE WAS SIGNIFICANT NONPHYSIOLOGIC SENSING OF NOISE AND FLUCTUATING IMPEDANCES FROM THE LEAD. LATER THAT DAY THE LEAD INTEGRITY ALERT TRIGGERED. IT WAS FURTHER REPORTED THAT THERE WAS OVERSENSING, AND THAT THE PATIENT EXPERIENCED PAUSES WHICH CAUSED THE PATIENT TO FEEL LIGHTHEADED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED, A NEW PACE/SENSE LEAD WAS IMPLANTED, AND THE DEFIBRILLATION PORTION REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF A NEW DEVICE THERE WAS SIGNIFICANT NONPHYSIOLOGIC SENSING OF NOISE AND FLUCTUATING IMPEDANCES FROM THE LEAD. LATER THAT DAY THE LEAD INTEGRITY ALERT TRIGGERED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT ASKU LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB