BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2123462 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02363
    Event Type
    Injury
    Date Received
    June 14, 2011
    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
    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. EVALUATION SUMMARY FOR (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE BATTERY DEPLETION WAS SUSPECTED DUE TO HIGH OUTPUTS. ALSO THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BOTH HAD LOW IMPEDANCE. IT WAS ALSO NOTED THAT THE RV LEAD HAD A HIGH THRESHOLD AND THAT THE RA THRESHOLD COULD NOT BE TESTED DUE TO THE PATIENTS ATRIAL FIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED AND BOTH LEADS WERE CAPPED AND REPLACED. NO 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 87 YR Hospitalization| R