BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3864753 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07535
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY - A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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 MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2010; 419488 LEAD, IMPLANTED: (B)(6) 2009; D224TRK ICD, IMPLANTED (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL LEADS WERE TO BE EXTRACTED. THE LEFT VENTRICULAR (LV) LEAD WAS BEING EXTRACTED FIRST. THE LEAD WAS CUT AND TUGGED ON BUT WOULD NOT MOVE AS IT WAS CALCIFIED TO THE SUPERIOR VENA CAVA (SVC) WITH THE THREE OTHER LEADS AND COULD NOT BE REMOVED. THE LEAD WAS CUT AND LEFT IN THE BODY. THE RIGHT VENTRICULAR (RV) LEAD WAS THEN ATTEMPTED TO BE REMOVED. THAT LEAD WAS ALSO CALCIFIED TO ALL THE OTHER LEADS. THE RV LEAD WAS CUT AND LEFT IN THE BODY WITH A LOCKING STYLET ON. THE ATRIAL LEAD WAS CUT AND PREPARED FOR EXTRACTION. THE ATRIAL LEAD HAD HIGH PACING IMPEDANCE, LOW HIGH VOLT IMPEDANCE, UNDERSENSING AND A POSSIBLE FRACTURE. THE EXTRACTION OF THE ATRIAL LEAD WAS NEVER ATTEMPTED AS COMPLICATIONS FROM THE PROCEDURE STOPPED THE ATTEMPT. THE LEAD WAS LEFT IN THE BODY. DURING THE ATTEMPT TO FREE UP THE LEADS, THE SVC TORE AND THE PATIENT STARTED TO LOSE SIGNIFICANT BLOOD. THE PROCEDURE WAS STOPPED AND NOTHING ELSE WAS ATTEMPTED ONCE THE SVC BLEEDING HAD STOPPED. THE LEADS WERE EXTRACTED THROUGH A STERNECTOMY AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337794 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| L| R 7120 LEAD