BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 3033471 · Received April 3, 2013

    Report

    Report Number
    9614453-2013-00581
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PACEMAKER (PM) EXPERIENCED EARLY BATTERY DEPLETION; PM CHECK SHOWED "LESS THAN [ONE] MONTH" LEFT ON THE BATTERY. THE PM WAS REMOVED AND REPLACED, AND HAS BEEN RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137292 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00004 YR Hospitalization| R