BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA

    MDR report key: 3152697 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01219
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE BATTERY MEASUREMENT WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 MEDICAL PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2010. 5076-58 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT FOLLOW UP VISIT, DEVICE RESET WAS FOUND. THE DEVICE WAS REPROGRAMMED BACK TO ORIGINAL SETTING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252240 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization| R