BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991588 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02440
    Event Type
    Injury
    Date Received
    February 15, 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
    IL, 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

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN RECEIVING PATIENT ALERTS FOR THE LAST FIVE MONTHS. THE DOCTOR INTERROGATED THE DEVICE, AND FOUND THERE WAS A LEAD WARNING FOR HIGH IMPEDANCE. IT WAS FURTHER REPORTED THAT INTERMITTENT NOISE WAS NOTED ON THE ELECTROGRAM. THE LEAD WAS CAPPED 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 HAD BEEN RECEIVING PATIENT ALERTS FOR THE LAST FIVE MONTHS. THE DOCTOR INTERROGATED THE DEVICE, AND FOUND THERE WAS A LEAD WARNING FOR HIGH IMPEDANCE. THE LEAD WAS CAPPED 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R 7230 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7230 IMPLANTABLE PACEMAKER/CARDIO/DEFIB