BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2202017 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11261
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    WA, 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. EVALUATION SUMMARY FOR (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING, VENTRICULAR (NON-SUSTAINED TACHYCARDIA) NST LESS THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME. VENTRICULAR FIBRILLATION EQUAL 200 MS AVERAGE V-CYCLE ON (B)(6) 2011. INTERFERENCE/NOISE, VENTRICULAR SHORT INTERVAL COUNT (V-SIC) EQUALS 1267.3 COUNTS AVG/DAY, IN 9.90 DAYS, BETWEEN (B)(6) 2011. HIGH RESISTANCE/IMPEDANCE AND PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011. DAILY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT SPIKE INCREASE FOR RV PACE EQUAL TO 472 TO INF (UNFILTERED DATA) OHMS PEAK BETWEEN (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO AN APPARENT RIGHT VENTRICULAR (RV) LEAD FRACTURE. AN EVALUATION OF THE RV LEAD SHOWED HIGH LEAD IMPEDANCE AND THAT A PATIENT ALERT WAS TRIGGERED. THE LEAD HAD OVERSENSING AND NOISE WITH ARM MOVEMENT. THE PATIENT DESCRIBES PULLING THEMSELVES UP WITH THEIR LEFT ARM TO GET INTO A VEHICLE AND SOON AFTER THE SHOCKS STARTED TO OCCUR. THE LEAD WAS CAPPED AND REPLACED BY A NEW LEAD. NO FURTHER 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 71 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD