BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2954801 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02401
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    May 30, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THERE WERE NO ANOMALIES OBSERVED ON THE RETURNED LEAD PROXIMAL SEGMENT. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. THE FULL LEAD WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EXHIBITED HIGH IMPEDANCE MEASUREMENTS. THE LEAD REMAINS IN SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EXHIBITED HIGH IMPEDANCE MEASUREMENTS. THE LEAD REMAINS IN SERVICE. IT WAS FURTHER REPORTED THAT THE RV LEAD HAD AN APPARENT FRACTURE AND WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58675 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR