BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1924165 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13441
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED; THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED); THE HELIX WAS DISTORTED/BENT; THE OUTER TUBING OVERLAY HAD A COSMETIC ENVIRONMENTAL STRESS CRACK; BLOOD IN/ON THE HELIX/LOB MECHANISM. APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS TRYING TO EXTRACT THE RIGHT VENTRICULAR DEFIBRILLATION LEAD DUE TO INSULATION FAILURE. THERE WAS A KINK IN THE LEAD JUST BEFORE THE SUPERIOR VENA CAVA (SVC) COIL. THE STYLET WAS UNABLE TO GET PAST THE KINK. INFECTION WAS ALSO REPORTED. THE LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 1488TC COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1488TC COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB