BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 3993466 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14617
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY SHOWED BATTERY DEPLETION. THE LAST BATTERY MEASUREMENT RECORDED ON 16APR2014 WAS 2.61 VOLTS. THE ERI INDICATOR HAD NOT YET BEEN TRIGGERED. THE VOLTAGE TRIP MUST BE THREE MEASUREMENTS BELOW THE THRESHOLD OF 2.81 VOLTS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 407652 IMPLANTABLE PACING LEAD IMPLANTED (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY HAD A SUDDEN DROP IN VOLTAGE FROM 2.92 VOLTS TO 2.61 VOLTS IN A 3 MONTH PERIOD. THE DEVICE WAS ALSO UNABLE TO BE INTERROGATED BY THE REMOTE WIRELESS MONITOR. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471564 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 407645 IMPLANTABLE PACING LEAD