BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811841 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17136
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    PRODUCT EVENT SUMMARY: THE LEAD SEGMENTS WAS RETURNED AND ANALYZED. THE LEAD CONDUCTOR WAS FRACTURED AND THE DISTAL END ELECTRODES WERE DAMAGED, PULLED/STRETCHED/OVERSTRESS AND COVERED IN BLOOD. THE HELIX WAS DISTORTED BENT. THERE WAS INSULATION BREACH WITH THE OUTER INSULATION CUT AND OVERLAY TUBING CUT AND MELTED. THE LEAD HAD COSMETIC DEPRESSION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING: THERE WERE THREE VENTRICULAR NST<(><<)>=190 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 03:47:13 AND 04:52:49. THERE WERE TWO VF<(><<)>=210 MS AVERAGE V-CYCLE ON (B)(6) 2012 AT 12:49:24 AND 12:51:37. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: THERE WAS ONE PATIENT ALERT FOR OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 02:15:03. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX RV PACE= 496 TO 1040 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AFTER RECEIVING NUMEROUS SHOCKS DUE TO SHORT INTERVAL COUNTS (SIC.) IT WAS ALSO REPORTED THAT OVERSENSING WAS PRESENT AND REPRODUCIBLE WITH ARM MOVEMENT. IT WAS FURTHER REPORTED THAT THE RV LEAD FRACTURED AND THE LEAD INTEGRITY ALERT (LIA) TRIGGERED. THE RIGHT VENTRICULAR (RV) LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO FURTHER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD