BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1921748 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12678
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 8, 2010
    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
    FL, 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 "HIGH RESISTANCE/IMPEDANCE: RV PACE IMPEDANCE STEADY AT 800 OHMS AT IMPLANT, BEGINS LINEAR RISE IN (B)(6) 2009 FROM ~800 OHMS TO ~1400 OHMS IN (B)(6) 2010. TREND DISPLAYS CHARACTERISTICS OF CHRONIC RISING LEAD IMPEDANCE". THE ANALYSIS ALSO REVEALED "SENSING: NO ANOMALIES FOUND. NO NON-PHYSIOLOGICAL NSTS (V-V CYCLE <220MS) RECORDED" AND "NOISE: NO ANOMALIES FOUND. 3 SI COUNTS OVER 1994 DAYS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR PACE/SENSE /DEFIB LEAD HAD DEVELOPED HIGH PACING THRESHOLDS AND GRADUALLY INCREASING PACING IMPEDANCES. THE PACING PORTION OF THE LEAD WAS ABANDONED AND A NEW PACE/SENSE LEAD ONLY IMPLANTED. THE HIGH VOLTAGE ELECTRODE PORTION OF THE LEAD IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 6940 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB