BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2952773 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00706
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. CONCOMITANT PRODUCT: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THERE WAS OVERSENSING WITH VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN EQUAL TO 210 MILLISECONDS BETWEEN (B)(6) 2012. ALSO, THERE WAS A PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012.

    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 A PATIENT ALERT WAS SOUNDING FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO OVERSENSING. ALSO, THE RV LEAD THRESHOLD HAD INCREASED TO 5 VOLTS AT 0.2 MILLISECONDS AND THERE WAS A SUSPECTED FRACTURE. THE DETECTIONS AND THERAPIES WERE TURNED OFF UNTIL THE RV LEAD WAS CAPPED 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
    55453 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| R D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR