BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2130624 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03356
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 20, 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
    NC, 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.

    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 DEVICE WAS RETURNED AND ANALYZED. CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC DUE TO HAVING SYMPTOMS THAT APPEARED TO BE RELATED TO PACING AT VVI 65. IT WAS ALSO REPORTED THAT THE CLINIC HAD THE PATIENT SEND A CARELINK TRANSMISSION TO THE CLINIC WHICH SHOWED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR STATUS AFTER LESS THAN FIVE YEARS POST IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC DUE TO HAVING SYMPTOMS THAT APPEARED TO BE RELATED TO PACING AT VVI 65. IT WAS ALSO REPORTED THAT THE CLINIC HAD THE PATIENT SEND A CARELINK TRANSMISSION TO THE CLINIC WHICH SHOWED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR STATUS AFTER LESS THAN FIVE YEARS POST IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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 85 YR Hospitalization| L| R 1646T COMPETITOR IMPLANTABLE PACING LEAD| 1646T COMPETITOR IMPLANTABLE PACING LEAD| 1642T COMPETITOR IMPLANTABLE PACING LEAD| 1642T COMPETITOR IMPLANTABLE PACING LEAD