BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2131234 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03455
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED AS ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH BATTERY IMPEDANCE WAS LOGGED ON (B)(4)-2011, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(4)-2011. ADDITIONALLY, HIGH BATTERY IMPEDANCE LEAD TO ERI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED THE ELECTIVE REPLACEMENT INDICATOR PREMATURELY DUE TO HIGH BATTERY IMPEDANCE. IT WAS FURTHER REPORTED BY THE PATIENT THAT THE PACEMAKER "CUT OFF." THE "BATTERY WAS FINE" AND FOUR DAYS LATER THE HEART WAS FLUTTERING AND WAS TOLD THE PACEMAKER "CUT OFF." IT WAS TESTED IN THE EMERGENCY ROOM (ER) AND THE PATIENT WAS TRANSPORTED BY AMBULANCE TO HAVE THE PACEMAKER REPLACED. THE PATIENT ALSO REPORTED "MILD CONGESTIVE HEART FAILURE" AND DOESN'T KNOW IF THAT WAS FROM THE "FAULTY PACEMAKER." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED THE ELECTIVE REPLACEMENT INDICATOR PREMATURELY DUE TO HIGH BATTERY IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEADS