BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 2790830 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05330
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT OF A NEW PULSE GENERATOR THERE WAS RIGHT ATRIAL OVERSENSING NOTED, PARTICULARLY WITH ARM MOTION AND ISOMETRICS. A SETSCREW PROBLEM WAS FOUND. THE DEVICE AND ATRIAL LEAD REMAIN IN USE AND FURTHER INTERVENTION IS NOT PLANNED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other 5076 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD