BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4833810 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06932
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 31, 2015
    Report Date
    March 31, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, POST IMPLANT, THE PATIENT WAS IN SEVERE PAIN ESPECIALLY WITH RIGHT VENTRICULAR (RV) PACING. THE THRESHOLD WAS HIGH AND THE R WAVES HAD DIMINISHED. AN RV LEAD PERFORATION WAS SUSPECTED. THE LEAD WAS REVISED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378517 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| L| R DTBA1Q1 ICD, 459878 LEAD, 5076-45 LEAD