BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2200615 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03602
    Event Type
    Injury
    Date Received
    August 11, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND PRELIMINARY ANALYSIS FOUND THAT THE DEVICE WAS PROGRAMMED ODO. FURTHER TESTING REVEALED A NO OUTPUT CONDITION IN ATRIAL AND VENTRICLE CHAMBERS AND A MICROSCOPIC VISUAL FOUND FRACTURED HYBRID WIRES. THE LIFTED WIRES WERE THE RESULT OF FRACTURES DUE TO FATIGUE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO A PATIENT CONDITION UNRELATED TO THE PERFORMANCE OF THE DEVICE. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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 60 YR Hospitalization| R (B)(4) X2 IMPLANTABLE PACING LEADS