BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPULSE DR

    MDR report key: 3992414 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14838
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED FAULTY LOW BATTERY VOLTAGE MEASUREMENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MODEL: 5568-53, LEAD; IMPLANT: 2007 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING IN-OFFICE TESTING THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) BATTERY VOLTAGE DISPLAYED LOWER THAN EXPECTED WITH THE ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS AS OK. THIS IS A KNOWN BEHAVIOR THAT CAN AFFECT THE BATTERY VOLTAGE MEASUREMENT FOR BRADY PACEMAKERS. OCCURRENCE OF THE ISSUE DOES NOT IMPACT PATIENT SAFETY AND THE DEVICE WILL REPLACE THE FALSE LOW BATTERY VOLTAGE WITH A CORRECT VALUE WITHIN 3 HOURS OUTSIDE OF A FOLLOW-UP SESSION. THE IPG 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
    472556 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR 5076-58, LEAD