BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO

    MDR report key: 3032206 · Received April 3, 2013

    Report

    Report Number
    2649622-2013-02591
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    January 28, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2013. OF NOTE, THE REPORTABLE MALFUNCTION OF T-WAVE OVERSENSING (TWOS) IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2013. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2013 AND REVEALED THE PATIENT IS DECEASED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE, BEING SUBMITTED AS A 30-DAY REPORT. (B)(4). D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD): IMPLANTED: (B)(6) 2011. A 419688 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2009.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS VARIOUS SPIKE INCREASES FOR MAX VENTRICULAR PACE BIPOLAR IMPEDANCE EQUALING 437 TO 684 OHMS RANGE BETWEEN (B)(6) 2012 AND (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THERE WAS T-WAVE OVERSENSING (TWOS). ATTEMPTS TO PROGRAM AROUND OVERSENSING WERE MADE BUT WERE UNSUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY THREE WEEKS AFTER THE INITIAL REPORT OF TWOS. THE CAUSE AND CIRCUMSTANCES OF PATIENT DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THERE WAS T-WAVE OVERSENSING (TWOS). ATTEMPTS TO PROGRAM AROUND OVERSENSING WERE MADE BUT WERE UNSUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY THREE WEEKS AFTER THE INITIAL REPORT OF TWOS. THE CAUSE AND CIRCUMSTANCES OF PATIENT DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137211 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| R