BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2122480 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07856
    Event Type
    Injury
    Date Received
    June 13, 2011
    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 Location
    MA, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE INITIAL REPORT OF INFECTION WAS RECEIVED ON (B)(6) 2011 AND IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORTING (ASR) THAT WOULD HAVE BEEN DUE ON (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 THAT REVEALED AN OUT OF SPEC ANALYSIS FOR THE 6947. AS THERE IS NEW INFORMATION, THIS LEAD NO LONGER QUALIFIES FOR ASR, AND IS THEREFORE BEING SUBMITTED AS A BIMONTHLY REPORT. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC CUT, AND THERE WAS BLOOD IN/ON HELIX/LOBE MECHANISM AND MECHANISM (SLEEVE HEAD).

    Description of Event or Problem · 1

    INFECTION WAS REPORTED. THE RIGHT VENTRICULAR EAD WAS REMOVED AND REPLACED A FEW DAYS LATER. THE LEAD WAS RETURNED TO THE MANUFACTURE, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB