BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791481 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14530
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    February 8, 2018
    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 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 PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE DEVICE IS NO LONGER INCLUDED AS PART OF THE FIELD ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE PATIENT WAS WALKING DOWN THE STREET, THE PATIENT RECEIVED SEVERAL SHOCKS DUE TO NOISE AND OVERSENSING. THE OVERSENSING WAS ON THE TIP TO RING. THERE WAS ALSO A REPORT OF IMPEDANCE SPIKE AND POSSIBLE LEAD FRACTURE. THE PATIENT ALSO CALLED TO REPORT RECEIVING MULTIPLE SHOCKS WHILE "NOT HAVING A HEART ATTACK". THE PATIENT UNDERSTOOD THE "LEAD WAS COMING APART". THE PATIENT HAD LEAD "TURNED OFF" AND RECENTLY HEARD BEEPING FROM THE DEVICE. SEVERAL FOLLOW UP ATTEMPTS WERE MADE AND NO INFORMATION WAS OBTAINED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER NOTED THAT THE LEAD HAD BEEN CAPPED AND REPLACED. THE LEAD WAS RECENTLY EXPLANTED AND RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD