BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922830 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13099
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 14, 2010
    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
    NJ, 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 AND ANALYZED. THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL. THERE WAS BLOOD/BODY FLUID IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD. TIP SEAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HELIX WOULD NOT DEPLOY AT ALL AFTER MANY ATTEMPTS. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS IMPLANTED SUCCESSFULLY. OVERSENSING WAS OBSERVED WHEN PLACING THE DEVICE IN THE POCKET AFTER ATTACHING IT TO THE NEW LEAD. THE DEVICE REMAINS IN USE. 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 83 YR Hospitalization| O| R 4194 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD