BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA

    MDR report key: 3051288 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05920
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE USED DURING IMPLANT BUT ELECTIVE REPLACEMENT INDICATOR (ERI) ALERT WAS PRESENT. THEREFORE THE DEVICE WAS REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152272 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR