BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4833468 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07072
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    October 15, 2014
    Report Date
    April 9, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT NO ANOMALIES WERE FOUND ON THE LEAD.

    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).

    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 APPROXIMATELY ONE MONTH AFTER INITIAL IMPLANT AN X-RAY CONFIRMED LEFT VENTRICULAR (LV) LEAD DISLODGEMENT. A LOSS OF CAPTURE AND HIGH THRESHOLDS WERE ALSO NOTED. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD APPEARED TO HAVE "PULLED BACK." THE PHYSICIAN FIRST ATTEMPTED TO REPOSITION THE LV LEAD. HOWEVER, DUE TO STENOSIS AND A DIFFICULT PATIENT ANATOMY, THE PHYSICIAN ELECTED TO REMOVE THE LEAD AND ABANDON THE PROCEDURE AFTER MULTIPLE ATTEMPTS. NEXT, IT WAS NOTED THAT "SOME SLACK HAD PULLED BACK" ON THE RA LEAD BUT OTHERWISE, THE LEAD WAS "COMPLETELY FUNCTIONAL." NO CHANGES WERE MADE TO THE RA LEAD AND IT REMAINS IN USE. LASTLY, IT WAS NOTED THAT DURING REPOSITIONING OF THE LV LEAD, R WAVE SENSING HAD DROPPED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ATTEMPTED TO REPOSITION THE RV LEAD BUT THE HELIX WOULD NOT RETRACT. SLACK WAS ADDED TO THE RV LEAD, CHANGING THE SENSE VECTOR AND RESULTING IN IMPROVED R WAVES. THE RV LEAD REMAINS IN USE. APPROXIMATELY ONE MONTH AFTER THE REPOSITIONING ATTEMPT, THE PHYSICIAN PLACED AN EPICARDIAL LV LEAD WHICH NOW REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373763 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 5076-45 LEAD, DTBA1QQ CRT-D