BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA

    MDR report key: 2951965 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00076
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 #EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THIS PACEMAKER WAS IMPLANTED IN (B)(6) 2006. ERI SHOWN IN THE DISPLAY IN 2012 (B)(6). EARLY BATTERY DEPLETION OCCURS WITHIN WARRANTY. ERI IS INDICATED ON (B)(6) 2012 AT 2.81V, AS EARLIER THAN EXPECTED CLAIMING TO FOR AVERAGE 6 MONTHS FOR LAST INTERROGATION IN FIRST WEEK OF (B)(6). RV OUTPUT IS UNDER HIGH THRESHOLD (5V AT 0.15MS) BEFORE BEING EXPLANTED. ((B)(4)) US FDA MDR IT WAS REPORTED THAT THE DEVICE TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED ANDREPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56784 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. (SMO) SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R