BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3991804 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07947
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    November 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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 INDICATES OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) AND RIGHT VENTRICULAR LEAD INTEGRITY ALERT. IT WAS NOTED THAT BEGINNING 2014-05-27, THE SIC WAS UP TO 41; THERE WAS HIGH-RATE NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH EVIDENCE OF LEAD NOISE OVERSENSING. AN RIGHT VENTRICULAR (RV) LEAD INTEGRITY WARNING OCCURRED 2014-05-30 FOR SIC GREATER THAN 30 IN 3 DAYS AND HIGH RATE NST EVENTS.

    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. CONCOMITANT PRODUCT: 5076 LEAD, IMPLANTED: (B)(6) 2009; 4194 LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    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 LEAD INTEGRITY ALERT WAS TRIGGERED DUE TO NON-SUSTAINED TACHYCARDIA (NST) EPISODES AND INCREASED SHORT INTERVAL COUNTS (SIC). THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE AN UNSTABLE SENSING HISTORY WITH SUSPECT OF A POSSIBLE FRACTURE. THE DEVICE WAS REPROGRAMMED AND THE LEAD WAS CAPPED WITH A NEW LEAD SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472443 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 69436536

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R D384TRG ICD