BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1923115 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06052
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 6, 2010
    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
    MA, 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. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.55 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.92 V. 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) 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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATES A LOW TELEMETERED BATTERY VOLTAGE. ON (B)(4) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.55 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.92 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE VOLTAGE WAS 2.55V YET IT HAD NOT TRIPPED ELECTIVE REPLACEMENT INDICATOR. LATER THE DEVICE BATTERY WAS REPORTED AT 2.97V. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE VOLTAGE WAS 2.55V YET IT HAD NOT TRIPPED ELECTIVE REPLACEMENT INDICATOR. LATER THE DEVICE BATTERY WAS AT 2.97V. IT WAS FURTHER REPORTED THAT ELECTIVE REPLACEMENT INDICATOR TRIGGERED PREMATURELY, POSSIBLY 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 55 YR Hospitalization| O| R 1688T X2 COMPETITOR IMPLANTABLE PACING LEAD| 1688T X2 COMPETITOR IMPLANTABLE PACING LEAD