BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811701 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16137
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 10, 2012
    Report Date
    September 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THERE WERE NO IRREGULARITIES IN THE INSULATION NOTED AT THE TIME OF ANALYSIS. NO CUTS, TEARS, KINKS, WEAR OR ANY OTHER ANOMALIES WERE VISIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN APPROXIMATELY TWO MONTHS POST IMPLANT THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. WHEN THE PHYSICIAN OPENED THE POCKET AN "IRREGULARITY IN THE INSULATION" OF THE VENTRICULAR LEAD WAS SEEN. THE LEAD WAS ON TOP OF THE DEVICE AND WAS SUTURED ON THE SUTURE SLEEVE AS WELL AS DOWN THE LEAD BODY. IT WAS ALSO REPORTED THAT THE LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. THE DEVICE WAS INTERROGATED AND THERE WAS NO CAPTURE ON THE RIGHT VENTRICULAR LEAD AND SENSING WAS POOR. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB