BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990786 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08480
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    August 1, 2013
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: D154AWG, ICD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. FURTHER TROUBLESHOOTING FOR A COIL FRACTURE REVEALED THE RV COIL ALSO MEASURED HIGH IMPEDANCE. THE PHYSICIAN DECIDED TO REPLACE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WITH A NEW MODEL DEVICE THAT ALLOWED FOR DISABLING OF THE SVC COIL. THE LEAD WAS REPROGRAMMED TO TURN OFF THE SVC COIL FROM THE HIGH VOLTAGE CONFIGURATION. AFTER DEVICE REPLACEMENT, RV COIL IMPEDANCE WAS WITHIN NORMAL VALUES. THE LEAD 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
    469562 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 5076-52 LEAD