BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2003543 · Received March 1, 2011

    Report

    Report Number
    2649622-2011-03120
    Event Type
    Injury
    Date Received
    March 1, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED; PARTIAL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. THE DEFIB CONDUCTOR WAS FRACTURED AND DISTORTED. BLOOD/BODY FLUID WAS OBSERVED ON SEVERAL CONDUCTS (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY WAS MELTED, BREACHED/CUT AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. THE OUTER INSULATION WAS TORN, BREACHED/CUT AND HAD COSMETIC DEPRESSIONS. A WHITE SUBSTANCE WAS OBSERVED ON THE EXPOSED DEFIB COIL. THE HELIX WAS DISTORTED/BENT AND BLOOD WAS OBSERVED. THE LEAD WAS STRETCHED AND FLEXED. THE LEAD APPEARS TO HAVE BEEN IMPLANTED WITH A BEND IN IT AT THE FRACTURE SITE. THE ANCHORING SLEEVE FIXATION SITE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURE AFTER BEING EXPLANTED WITH NO INFORMATION GIVEN. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP REVEALED THAT THE LEAD WAS FRACTURED AND THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS THAT HURT. THE LEAD WAS EXPLANTED AND REPLACED. 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 14 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB