BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3864745 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07525
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. ANALYSIS REVEALED THAT THE EXPOSED SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION COILS HAD BECOME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THE EXPOSED RV DEFIBRILLATION COIL HAD BECOME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING AND THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THAT AN IN-VIVO INSULATION BREACH OR CONDUCTOR FRACTURE WAS NOT OBSERVED AND THAT THE LEAD WAS RETURNED WITH NON-SEVERE EXPLANT DAMAGE. THEY ALSO NOTED THAT HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE ALL PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV(RIGHT VENTRICULAR) PACING LEAD WAS VARIABLE AND INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THERE WERE 22 VENTRICULAR-SICS SINCE LAST SESSION 2.5 DAYS AGO AND 5 NON-SUSTAINED TACHYCARDIA EPISODES WITH CYCLE LENGTH INTERVALS LESS THAN 220 MS BETWEEN (B)(6) 2014. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2014 FOR LEAD IMPEDANCE AND VENTRICULAR-SICS. RV IMPEDANCE VARIES BETWEEN 500 AND 1300 OHMS OVER PREVIOUS 8 WEEKS.

    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 RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH IMPEDANCE LEVELS AS WELL AS OVERSENSING. A LEAD INTEGRITY ALERT (LIA) HAD BEEN TRIGGERED AND A FRACTURE IN THE LEAD WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338276 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R