BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3860755 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05313
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. (B)(4).

    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 THE SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD JUMPED FROM 62 OHMS TO 130 OHMS OVER A TWO DAY PERIOD. IT WAS FURTHER REPORTED THAT NOISE WAS REPRODUCED DURING ISOMETRIC EXERCISES. IT WAS BELIEVED THAT THE RV LEAD HAD POSSIBLY FRACTURED. NO SHOCKS OR INAPPROPRIATE THERAPY WERE DELIVERED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE LEAD WAS PARTIALLY EXPLANTED AND REPLACED AND THE DISTAL PORTION OF THE LEAD WAS CAPPED AND LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337082 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R D224VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR