BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 2811196 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05951
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1512-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: (B)(4). THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF "FEELING BAD" FOR A COUPLE OF WEEKS DUE TO PATIENT'S HEART RATE BEING APPROXIMATELY 30 BEATS PER MINUTE. THE RIGHT VENTRICULAR (RV) LEAD WAS REPORTED HAVE UNDEFINED PACING IMPEDANCE MEASUREMENTS AND NO PACING WAS OBSERVED DURING A REMOTE MONITORING VISIT. IT WAS ALSO REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR. DURING THE PROCEDURE, ONCE THE LEAD WAS ATTACHED TO THE ANALYZER AND NEW DEVICE, IT WAS WORKING WELL. THE DEVICE WAS EXPLANTED AND REPLACED. 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 SIGMA 300 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SSR303

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R