BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1863211 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10587
    Date Received
    October 9, 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
    TN, 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.

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 IN SEGMENTS WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS NOTED ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX/LOBE MECHANISM, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RVC AND SVC IMPEDANCES HAVE BEEN FLUCTUATING GREATLY RANGING FROM 60 OHMS TO 200 OHMS. IT WAS ALSO REPORTED THAT THE RVC AND SVC IMPEDANCES ON THE LEAD WERE GREATER THAN 200 OHMS, WHICH TRIGGERED A PATIENT ALERT. IT WAS LATER REPORTED THAT THE PATIENT'S LEAD NEEDED TO BE REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV AND SVC IMPEDANCES HAVE BEEN FLUCTUATING GREATLY RANGING FROM 60 OHMS TO 200 OHMS. IT WAS ALSO REPORTED THAT THE RV AND SVC IMPEDANCES ON THE LEAD WERE GREATER THAN 200 OHMS, WHICH TRIGGERED A PATIENT ALERT. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2010, IT WAS LATER REPORTED THAT THE PATIENT'S ENTIRE SYSTEM NEEDED TO BE REMOVED DUE TO INFECTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR AND SVC IMPEDANCES HAVE BEEN FLUCTUATING GREATLY RANGING FROM 60 OHMS TO 200 OHMS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR AND SVC IMPEDANCES ON THE LEAD WERE GREATER THAN 200 OHMS, WHICH TRIGGERED A PATIENT ALERT. THE LEAD IS STILL 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 ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB