BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1991199 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00843
    Event Type
    Injury
    Date Received
    February 15, 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
    TN, 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. 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. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE CONDITION OCCURRED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE CONDITION OCCURRED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE CONDITION OCCURRED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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, ANALYZED, AND 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 IMPEDANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE CONDITION OCCURRED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY PROBLEMS DURING THE DEVICE INTERROGATION AND THE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED FOR LOW BATTERY VOLTAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO POSSIBLE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY PROBLEMS DURING THE DEVICE INTERROGATION AND THE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED FOR LOW BATTERY VOLTAGE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. IT WAS LATER REPORTED THAT ANALYSIS OF DEVICE DATA SHOWED "DELTA V BATTERY TRIP(PED)" 4 DAYS AFTER THE SOFTWARE UPGRADE WAS LOADED ONTO THE DEVICE; INDICATING A HIGH BATTERY IMPEDANCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY PROBLEMS DURING THE DEVICE INTERROGATION AND THE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED FOR LOW BATTERY VOLTAGE. THE DEVICE REMAINS IN USE. 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 63 YR Hospitalization| O| R 3830 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD