BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1811970 · Received August 24, 2010

    Report

    Report Number
    2649622-2010-08869
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND FOUND HIGH RESISTANCE/IMPEDANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THE ALERT TONE DUE TO THE LEAD INTEGRITY ALERT TRIGGERING ON (B)(6) 2010 AT 9 AM. UPON REVIEW OF THE (B)(4) TRANSMISSION, IT WAS SEEN THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE INCREASED FROM 500OHMS TO 1200OHMS ON (B)(6) 2010 AND (B)(6) 2010 IT MEASURED >4000OHMS. THE SHORT INTERVAL COUNTER IS 433 SINCE (B)(6) 2010 AND THERE ARE SEVERAL NON-SUSTAINED EPISODES WITH ONE VF SENSE ON THE STORED ELECTROGRAM'S. UPON REVIEW OF THE MANUFACTURER'S DATA BASE IT WAS DETERMINED THAT THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THE ALERT TONE DUE TO THE LEAD INTEGRITY ALERT TRIGGERING ON JULY 24, 2010 AT 9 AM. UPON REVIEW OF THE CARELINK TRANSMISSION, IT WAS SEEN THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE INCREASED FROM 500OHMS TO 1200OHMS ON (B)(6) 2010 AND (B)(6) 2010 IT MEASURED >4000OHMS. THE SHORT INTERVAL COUNTER IS 433 SINCE (B)(6) 2010 AND THERE ARE SEVERAL NON-SUSTAINED EPISODES WITH ONE VF SENSE ON THE STORED ELECTROGRAM'S. UPON REVIEW OF THE MANUFACTURER'S DATA BASE, IT WAS DETERMINED THAT THE LEAD WAS REMOVED AND REPLACED. 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 S ASKU LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD