BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1854902 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09271
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GRADUAL IMPEDANCE INCREASE, IMPEDANCE WAS HIGH, AND THE LEAD INTEGRITY ALERT HAD TRIGGERED. NO NOISE WAS OBSERVED ON THE ELECTROGRAM WHEN THE PATIENT PERFORMED PHYSICAL MOVEMENTS. THE ALERT UPPER LIMIT HAS BEEN REPROGRAMMED TWICE TO A HIGHER VALUE. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE LEAD WAS CAPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING A NEW LEAD WAS PLACED FOR PACING AND SENSING AND THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GRADUAL IMPEDANCE INCREASE, IMPEDANCE WAS HIGH, AND THE LEAD INTEGRITY ALERT HAD TRIGGERED. NO NOISE WAS OBSERVED ON THE ELECTROGRAM WHEN THE PATIENT PERFORMED PHYSICAL MOVEMENTS. THE ALERT UPPER LIMIT HAS BEEN REPROGRAMMED TWICE TO A HIGHER VALUE. THE LEAD 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

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