BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810863 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16560
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    March 19, 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
    PA, 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 FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED CUT. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS BLOOD IN/ON DISTAL ELECTRODE, AND THE LEAD APPEARED DAMAGED AT IMPLANT. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND TWO VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 211 MS OCCURRED ON (B)(6) 2012 AT 19:14: 08 AND 19:14: 13. FOUR VENTRICULAR FIBRILLATION EPISODES OF LESS THAN OR EQUAL TO 200 MS AVERAGE V-CYCLE OCCURRED ON (B)(6) 2012 BETWEEN 18:55:45 AND 18:58:56. FIVE LEAD FAILURE PREDICTOR HIGH RATE-NON-SUSTAINED EPISODES OF LESS THAN OR EQUAL TO 21 MS AVERAGE V-CYCLE OCCURRED ON (B)(6) 2012 BETWEEN 18:37:46 AND 18:39:02. VENTRICULAR SHORT INTERVAL COUNT V-SIC=1268 COUNTS, IN 24.38 DAYS, BETWEEN (B)(6) 2012. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2012 18:38:42.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH INAPPROPRIATE SHOCKS. INTERROGATION REVEALED OVER SENSING AND FLUOROSCOPY SHOWED DISLODGMENT OF THE RIGHT VENTRICULAR LEAD INTO THE RIGHT ATRIUM. THE LEAD WAS EXPLANTED AND REPLACED. DURING EXPLANT THE HELIX WOULD NOT RETRACT AND AN INSULATION BREACH OF THE LEAD WAS NOTED. NO FURTHER PATIENT COMPLICATIONS WERE NOTED 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 65 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB