BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2953394 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01940
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED HIGH IMPEDANCE IN THE BATTERY. ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL ELECTRICAL RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET (POR) HAD OCCURRED DUE TO RADIATION. THEN THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO BATTERY IMPEDANCE. 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
    57624 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5054 IMPLANTABLE PACING LEAD