BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 2533592 · Received April 12, 2012

    Report

    Report Number
    6000144-2012-02582
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    February 27, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    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. THERE WAS A BATTERY VOLTAGE MEASUREMENT ERROR. INCORRECT LOW VALUE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW BATTERY VOLTAGE OF 2.05 VOLTS WAS NOTED BUT THE BATTERY WAS NOT AT ELECTIVE REPLACEMENT INDICATOR (ERI). THIS IS A KNOWN ISSUE, AND THE FALSE LOW BATTERY VOLTAGE IS REPLACED WITH THE CORRECT VALUE AT THE NEXT THREE HOUR UPDATE. THE DEVICE REMAINS IN USE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 4076 X2 IMPLANTABLE PACING LEADS| 4076 X2 IMPLANTABLE PACING LEADS