BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 3071698 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06695
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 12, 2012
    Report Date
    February 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. POWER ON RESET OCCURRED. CRITICAL RAM PARITY ERROR WAS RECORDED ON (B)(6) 2012. PARITY ERROR IS CONSIDERED LOW SEVERITY AND THE DEVICE SHOULD BE ABLE TO RECOVER AFTER RESET. IT WAS FURTHER REPORTED THAT THE PATIENT'S HOME WAS STRUCK BY LIGHTNING ON THE DAY THE RESET OCCURRED. PRODUCT: 4574 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AN ELECTRICAL RESET OCCURRED IN THE DEVICE AND THE ALERT WAS CLEARED. IT WAS FURTHER REPORTED THAT THE PATIENT'S HOME WAS STRUCK BY LIGHTNING ON THE DAY THE RESET OCCURRED. 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
    172622 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention 4074 IMPLANTABLE PACING LEAD