BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922753 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13069
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED THERE WAS OVERSENSING. THERE WERE 2 VENTRICULAR FIBRILLATION EPISODES WITH LESS THAN 200MS AVERAGE V-CYCLE LENGTHS ON (B)(6) 2010. ANALYSIS ALSO NOTED INTERFERENCE/NOISE WAS PRESENT. THE VENTRICULAR SHORT INTERVAL COUNT AVG/DAY (B)(6) 2010 WAS GREATER THAN 900.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD DIMINISHING R-WAVES. AFTER THE SENSING POLARITY WAS CHANGED, THE DEVICE ACCRUED OVER 12,000 SHORT INTERVAL COUNTS. SENSING ON THE LEAD WAS THEN PROGRAMMED FROM INTEGRATED BIPOLAR TO TRUE BIPOLAR. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD DIMINISHING R-WAVES. AFTER THE SENSING POLARITY WAS CHANGED, THE DEVICE ACCRUED OVER 12,000 SHORT INTERVAL COUNTS. SENSING ON THE LEAD WAS THEN PROGRAMMED FROM INTEGRATED BIPOLAR TO TRUE BIPOLAR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB