BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2695092 · Received August 13, 2012

    Report

    Report Number
    2649622-2012-09443
    Event Type
    Injury
    Date Received
    August 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 LEAD WAS NOT RECEIVED FOR EVALUATION. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT LEAD INTEGRITY ALERT TRIGGERED. THE PROGRAMMER DATA SHOWS ONE LEAD INTEGRITY ALERT ON (B)(6) 2012, 02:15:03. THERE WAS OVERSENSING AS THERE WAS TWELVE VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 210 MS BETWEEN (B)(6) 2012, 11:47:48 AND (B)(6) 2012, 17:50:36. THERE WAS ALSO HIGH RESISTANCE/IMPEDANCE. THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012, 02:15:03 AND (B)(6) 2012, 02:15:03. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX RV PACE EQUALING 504 TO 3200 OHMS PEAK BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD SOME HIGH IMPEDANCE MEASUREMENTS, THE LEAD INTEGRITY ALERT WAS ACTIVATED, AND THERE WERE NST (NON-SUSTAINED TACHYCARDIA) EPISODES WITH OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB