BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4161635 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11474
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THERE WAS EVIDENCE OF NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH SHORT INTERVALS BASED ON LEAD INTEGRITY ALERT (LIA) TRIGGER. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) AND (B)(6)-2014 FOR LEAD IMPEDANCE AND NST¿S. RIGHT VENTRICULAR (RV) PACE IMPEDANCE STEADY AT 530 OHMS THROUGH (B)(6)-2014, RISES OUT OF RANGE (1000 OHMS) WEEK OF (B)(6)-2014, SUBSEQUENT 4 WEEKS ARE 530-550 OHMS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO CHEST PAIN AND WAS HOSPITALIZED. A DEVICE INTERROGATION FOUND THAT A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO AN ISOLATED HIGH IMPEDANCE MEASUREMENT OF 1000 OHMS AND THEN THE IMPEDANCE DROPPED BACK DOWN TO A BASELINE OF 494 OHMS. A FRACTURE WAS SUSPECTED. THE INTERROGATION ALSO NOTED OVERSENSING AND NOISE ON THE ELECTROGRAMS AND ONE HIGH THRESHOLD MEASUREMENT. THE LEAD PARAMETERS WERE REPROGRAMMED AND THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PROGRAMMER HAD DIFFICULTY ESTABLISHING TELEMETRY AFTER THE INITIAL INTERROGATION. THE SOFTWARE WAS MANUALLY STARTED AND TELEMETRY WAS ESTABLISHED. THE PROGRAMMER 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
    639984 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R D224TRK ICD, 4196-88 LEAD