BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2051220 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01509
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 26, 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
    CO, 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.

    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): 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 DEVICE HAD AN ELECTRICAL RESET. DIAGNOSTIC DATA WAS CLEARED. FOLLOW-UP WAS UNABLE TO DETERMINE IF THE SOFTWARE UPDATE WAS RELOADED ONTO THE DEVICE. IT WAS LATER REPORTED THAT THE DEVICE HAD ANOTHER ELECTRICAL RESET. THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGER VOLTAGE CHANGED TO A LOWER VALUE WHEN THE DEVICE REVERTED BACK TO THE OLD SOFTWARE. FOLLOW-UP WITH THE CLINIC CONFIRMED THE PATIENT WAS SEEN SINCE THE RESET AND THE DEVICE WAS FUNCTIONING NORMALLY. THE DEVICE IS STILL IN USE. IT WAS LATER REPORTED THAT THE DEVICE INDICATED ELECTIVE REPLACEMENT (ERI) AND THERE WAS EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. DIAGNOSTIC DATA WAS CLEARED. FOLLOW-UP WAS UNABLE TO DETERMINE IF THE SOFTWARE UPDATE WAS RELOADED ONTO THE DEVICE. IT WAS LATER REPORTED THAT THE DEVICE HAD ANOTHER ELECTRICAL RESET. THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGER VOLTAGE CHANGED TO A LOWER VALUE WHEN THE DEVICE REVERTED BACK TO THE OLD SOFTWARE. FOLLOW-UP WITH THE CLINIC CONFIRMED THE PATIENT WAS SEEN SINCE THE RESET AND THE DEVICE WAS FUNCTIONING NORMALLY. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. DIAGNOSTIC DATA WAS CLEARED. FOLLOW-UP WAS UNABLE TO DETERMINE IF THE SOFTWARE UPDATE WAS RELOADED ONTO THE DEVICE. THE DEVICE IS STILL IN USE. 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 88 YR Hospitalization| O| R 5076 X2 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEADS