BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2122614 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07893
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 23, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED IN PART ON DEVICE RETURN AND ANALYSIS. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 AND ANALYSIS FOUND THAT THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL, THE OUTER INSULATION HAD A COSMETIC CUT, AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THE DISTAL CONDUCTOR WAS CUT, BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS OUTER INSULATION BREACH CUT, AND THERE WAS APPARENT EXPLANT DAMAGE. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE (S) HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY THAT MAY HAVE OCCURRED. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS WERE REMOVED AND REPLACED DUE TO SUSPECTED POCKET INFECTION. THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 77 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB