BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993946 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09032
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT: 5076-45 LEAD IMPLANTED: 2014-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH ABDOMINAL PAIN. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND LOW IMPEDANCE. AN ECHOCARDIOGRAPH WAS PERFORMED AND REVEALED RV LEAD PERFORATION AND PERICARDIAL EFFUSION. THE LEAD WAS REVISED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY.

    Description of Event or Problem · 1

    THE PRINCIPAL INVESTIGATOR (PI) DOES NOT FEEL THERE WAS A LEAD DISLODGEMENT. THE PI BELIEVES THE PERICARDIAL EFFUSION WAS DUE TO THE COMBINATION OF ANITCOAGULATION AND ANTIPLATELET THE PATIENT WAS ON AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470478 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| L| R DDBB1D4 ICD