BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1991152 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00838
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI ERI DUE TO HIGH BATTERY IMPEDANCE WAS TRIGGERED ON (B)(6) 2010, PRIOR TO EXPLANT. RAMWARE VERSION 8 WAS INSTALLED ON (B)(6) 2010. ANALYSIS OF DEVICE FOUND BATTERY HAD HIGH IMPEDANCE. THE INCORRECT RTT BATTERY VOLTAGE MEASUREMENTS ARE THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC SYMPTOMATIC. THE DEVICE BATTERY WAS AT ELECTIVE REPLACEMENT INDICATION, AND THE BATTERY WAS ALLEGED TO HAVE PREMATURELY DEPLETED. 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
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 4076X2 IMPLANTABLE PACING LEAD| 4076X2 IMPLANTABLE PACING LEAD| 4076X1 IMPLANTABLE PACING LEAD