BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2951804 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00242
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 03:58:05. AND THERE WERE THREE VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) LESS THAN OR EQUAL TO 150 MS BETWEEN (B)(6) 2012. SUBSEQUENTLY, THE PARTIAL LEAD WAS RETURNED IN SEGMENTS. THE LEAD WAS ANALYZED AND NO ANOMALIES WERE FOUND. APPARENT EXPLANT DAMAGE WAS NOTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB: (B)(6) 2011; (B)(4) COMPETITOR IMPLANTABLE PACING LEAD: 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT FOR THE RIGHT VENTRICULAR LEAD WAS TRIGGERED DUE TO NOISE. THE PHYSICIAN HAS DECIDED TO REPLACE THE LEAD AND ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) BECAUSE OF NOT KNOWING WHICH ON WAS CAUSING THE NOISE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56176 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD