BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 3051808 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05975
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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). CONCOMITANT MEDICAL PRODUCTS: 4092-52 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2011.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFECTION AND EROSION OCCURRED. IT WAS FURTHER REPORTED THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION AND LEAD DISLODGEMENT. THE DEVICE AND LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153185 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R