BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951690 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00171
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    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. PRODUCT EVALUATION SUMMARY: DEVICE INFORMATION WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THAT THERE WAS A LEAD IMPEDANCE ISSUE AS TWO LEAD INTEGRITY ALERTS WERE TRIGGERED ON (B)(6) 2012 FOR SHORT INTERVAL COUNTS AND ABNORMAL IMPEDANCE. ADDITIONALLY, IT WAS NOTED THAT THERE WAS OVERSENSING AS FIVE EPISODES OF LEAD FAILURE PREDICTOR TYPE OF VENTRICULAR-VENTRICULAR CYCLE LENGTH OF LESS THAN 180 MS WERE REGISTERED ON (B)(6) 2012. ADDITIONALLY IT WAS NOTED THAT ALERTS WERE TRIGGERED DUE TO REED SWITCH ACTIVATION. THE LOW-HIGH FREQUENCY ALERTS ARE OBSERVED FOR REED SWITCH CLOSED ON (B)(6) 2012. ALSO A "NO REASON" ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALERT WAS TRIGGERED FOR LEAD INTEGRITY. THE RIGHT VENTRICULAR LEAD WAS FOUND TO HAVE INCREASING IMPEDANCE AND OVERSENSING. A FRACTURE IS SUSPECTED. A LEAD REVISION IS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALERT WAS TRIGGERED FOR LEAD INTEGRITY. THE RIGHT VENTRICULAR LEAD WAS FOUND TO HAVE INCREASING IMPEDANCE AND OVERSENSING. A FRACTURE IS SUSPECTED. A LEAD REVISION IS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55622 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE DEFIBRILLATOR