BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810848 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15804
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY MELTED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS A LEAD INTEGRITY ALERT TRIGGERED WITH THE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012. ALSO, THERE WAS OVERSENSING WITH VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN EQUAL TO 210 MS ON (B)(4) 2012 AND VENTRICULAR FIBRILLATION LESS THAN EQUAL TO 180 MS AVERAGE V-CYCLE BETWEEN (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING OF NOISE ON THE FRACTURED RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. 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 68 YR Hospitalization| L| R D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4196 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD