BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1854951 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04341
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SAVE TO DISK REVIEW - BATTERY DEPLETION INDICATED/ERI. MEASUREMENT LOCK-UP PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE PACEMAKER DISPLAYED ELECTIVE REPLACEMENT INDICATOR (ERI) PARAMETERS VIA TRANSTELEPHONIC MONITORING AND THAT INTERROGATION OF BATTERY VOLTAGE/IMPEDANCE WAS NOT POSSIBLE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO 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 Other 5023M IMPLANTABLE PACING LEAD| 4523 IMPLANTABLE PACING LEAD