BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 3860880 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10494
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 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
    MI, 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 : 5076-45 NON-DEFIB LEAD, IMPLANTED (B)(6) 2009. (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 THAT DURING ROUTINE DEVICE INTERROGATION A PARTIAL POWER ON RESET WAS OBSERVED. THE PATIENT DENIED ANY KNOWN SOURCE OF INTERFERENCE BUT STATED HE HAD A "SHOCK LIKE" SENSATION AT DEVICE SITE ON TWO SEPARATE OCCASIONS. THE PATIENT WAS INFORMED THAT THE PARTIAL RESET SHOULD NOT CAUSE ANY SUCH SENSATION AND WAS RECOMMENDED TO GET A FULL EVALUATION OF DEVICE FUNCTION. 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
    342647 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention 5076-52 NON-DEFIB LEAD IMPLANTED (B)(6) 2009