BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2122101 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07834
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. 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). INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 THAT REVEALED AN OUT OF SPEC CONDITION FOR THE LEAD. 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 IN SEGMENTS WAS RETURNED AND ANALYZED AND FOUND THE DISTAL CONDUCTOR FRACTURED. THE DEFIB CONDUCTOR WAS FRACTURED AND DISTORTED, THE DISTAL CONDUCTOR DISTORTED, THE OUTER TUBING KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACK (ESC), EXPOSED DEFIB COIL HAD WHITE SUBSTANCE, THE OUTER OVERLAY TUBING HAD WHITE SUBSTANCE, THE OUTER INSULATION HAD COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED DUE TO INFECTION. THE LEAD WAS RETURNED, ANALYZED AND SUBSEQUENTLY 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD