BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6769530 · Received August 4, 2017

    Report

    Report Number
    2182208-2017-01046
    Event Type
    Death
    Date Received
    August 4, 2017
    Date of Event
    March 9, 2015
    Report Date
    July 5, 2017
    Manufacturer
    MEDTRONIC RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. POSSIBLE MODELS COULD INCLUDE (6935, 6935M, 6947, 6947M). WITHOUT THE SPECIFIC MODEL NUMBER(S), IT IS NOT POSSIBLE TO ASSURE THE SPECIFIC PRODUCT CORRECTION NUMBER REFERENCED IN THE ARTICLE IS LISTED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6) YEARS OLD. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TRANSVENOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD RELIABILITY: IMPLICATIONS FOR POSTMARKET SURVEILLANCE. JOURNAL OF THE AMERICAN HEART ASSOCIATION. 2015; 4(6):E001672. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE TACHY LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE LEAD ¿FAILURES,¿ WHICH INCLUDED OUT OF RANGE IMPEDANCE, OVERSENSING, INCREASED PACING THRESHOLD, DISLODGEMENT, INABILITY TO PROVIDE THERAPY DUE TO DEFECT, AND INSULATION BREACHES. THE ARTICLE NOTED PATIENT DEATHS. THE STATUS OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547965 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC RICE CREEK MFG 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| R