BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051315 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05536
    Event Type
    Injury
    Date Received
    April 12, 2011
    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
    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: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SENSING DIFFICULTIES WITH THE RIGHT VENTRICULAR LEAD. IN AN ATTEMPT TO REPOSITION THE LEAD, THE HELIX WOULD NOT EXTEND OR RETRACT. THE LEAD WAS EXPLANTED AND REPLACED. NO 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD