BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1926492 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06429
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 THE PATIENT FELL AND WAS INJURED AND WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. THE PATIENT HAD A HEART RATE IN THE 20'S AND HAD TO BE PACED EXTERNALLY. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE, NO CAPTURE, AND AN APPARENT FRACTURE. THE PACEMAKER AND LEAD WERE LEFT IN PLACE, PROGRAMMED TO ODO MODE, AND REPLACED WITH A NEW PACEMAKER AND LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD