BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 1921130 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05699
    Event Type
    Injury
    Date Received
    December 13, 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
    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 : (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED AND PRIMARY ANALYSIS REVEALED NO ANOMALIES. THE OUTER INSULATION WAS MELTED NEAR THE PROXIMAL END AND COSMETIC ENVIRONMENTAL STRESS CRACKING WAS FOUND AT VARIOUS LOCATIONS THROUGHOUT THE LEAD. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND AN AMOUNT OF TISSUE ON THE HELIX. (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. THE DEVICE COULD NOT CAPTURE WHEN THE PATIENT WENT FROM SITTING TO STANDING AND THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATION. ADDITIONALLY, THE RIGHT VENTRICULAR LEAD HAD THRESHOLDS THAT WERE VARIABLE AND HIGH. THE DEVICE AND LEAD WERE 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 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R