BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 3741783 · Received April 11, 2014

    Report

    Report Number
    3004209178-2014-06061
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    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
    MN, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED, ATRIAL AND VENTRICULAR BORES WERE ABLE TO HOLD A .1000 INCH PIN GAUGE. IS-1 LEADS WERE FULLY INSERTED INTO THE ATRIAL AND VENTRICULAR BORES; SETSCREWS WERE TIGHTENED TO ONE CLICK ON A MEDTRONIC TORQUE WRENCH AND SLIGHTLY TUGGED. THE RESULT WAS THE LEADS REMAINED IN ORIGINAL POSITION. IS-1 INSERTION GAUGE 060889 WAS INSERTED INTO THE BORE WITH NORMAL FORCE NO BINDING WAS FELT. CONCOMITANT MEDICAL PRODUCTS: 4068, IMPLANTABLE PACING LEAD, (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, THE DEVICE UNDERSENSED P WAVES. A NEW DEVICE WAS CONNECTED WHICH ALSO UNDERSENSED THE P WAVES. THE NEW DEVICE WAS PROGRAMMED AND 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
    224335 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention 5024M, IMPLANTABLE PACING LEAD