BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1924577 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13626
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 4, 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
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. THERE WAS HIGH RESISTANCE/IMPEDANCE AND TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON (B)(6) 2010. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAXIMUM RIGHT VENTRICULAR PACE EQUAL TO THREE HUNDRED AND EIGHTY-FOUR TO ONE THOUSAND, SEVEN HUNDRED AND SEVENTY-SIX OHMS WITH THE MAXIMUM BETWEEN (B)(6) 2010. THERE WAS OVERSENSING, AND THREE VENTRICULAR NON-SUSTAINED EPISODES WITH AN AVERAGE VENTRICULAR CYCLE LENGTH OF LESS THAN OR EQUAL TO TWO HUNDRED AND TEN MILLISECONDS BETWEEN (B)(6) 2010. ALSO NOTED WAS INTERFERENCE/NOISE WITH A VENTRICULAR SHORT INTERVAL COUNT EQUALING ONE HUNDRED, EIGHTY-FOUR AND SIX TENTHS COUNTS AVERAGE PER DAY, IN TEN AND NINETY-SIX HUNDREDTHS DAYS, BETWEEN (B)(6) 2010. FURTHER NOTED ON THE SAVE-TO-DISK REVIEW FROM THE PROGRAMMER SHOWS THE LEAD INTEGRITY ALERT WAS TRIGGERED ON (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED, EXPERIENCED HIGH IMPEDANCE, AND OVERSENSING, AND THERE WERE NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES RECORDED DUE TO NOISE. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO NOTED THAT THE REPLACEMENT LEAD WAS IMPLANTED ON THE RIGHT SIDE OF THE PATIENT DUE TO LACK OF VENOUS ACCESS ON THE LEFT SIDE. 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 QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB