BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1854909 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09150
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    February 1, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    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.

    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 RESISTANCE/IMPEDANCE INCREASE. VENTRICULAR PACE BIPOLAR IMPEDANCE RISES STEADILY FROM 779 OHMS THE WEEK OF (B)(6) 2009 TO GREATER THAN 3000 OHMS THE WEEK OF (B)(6) 2010. THE ANALYSIS ALSO REVEALED AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OBSERVED (B)(6) 2010. THE PATIENT ALERT FOR THIS PARAMETER IS SET AT 3000 OHMS.

    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 RESISTANCE/IMPEDANCE INCREASE. VENTRICULAR PACE BIPOLAR IMPEDANCE RISES STEADILY FROM 779 OHMS THE WEEK OF (B)(6) 2009 TO GREATER THAN 3000 OHMS THE WEEK OF (B)(6) 2010. THE ANALYSIS ALSO REVEALED AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OBSERVED (B)(6) 2010. THE PATIENT ALERT FOR THIS PARAMETER IS SET AT 3000 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD PACING IMPEDANCE AND CAPTURE THRESHOLD THAT WERE BOTH PERSISTENTLY RISING. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD PACING IMPEDANCE AND CAPTURE THRESHOLD THAT WERE BOTH PERSISTENTLY RISING. THE LEAD IS STILL IN USE. IT WAS LATER REPORTED THE RV LEAD HAD A STEADY INCREASE IN IMPEDANCE TO GREATER THAN 3000 OHMS. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO ASKU LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R 2187 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 2187 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 2187 IMPLANTABLE PACING LEAD