BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1864633 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05155
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 26, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. LOW TELEMETERED BATTERY VOLTAGE. ON 26-JUL-2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.66 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V.

    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 MODEL 4092 LEAD WAS REPORTED ERRONEOUSLY. THE LEAD WITH THE MALFUNCTION IS FOR A DIFFERENT PATIENT AND IS REPORTED IN (B)(4). EVALUATION SUMMARY (B)(4) 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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.66 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT TAKEN IN CLINIC HAD DECREASED FROM (B)(6) AGO. IT WAS ALSO REPORTED THAT THE SENSING INTEGRITY COUNT WAS HIGH ON THE RIGHT VENTRICULAR LEAD, AND THAT NOISE COULD BE REPRODUCED THROUGH POCKET MANIPULATION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED FOR EARLY BATTERY DEPLETION. FURTHER INFORMATION REVEALED THAT THE LEAD WAS REPORTED IN ERROR. THE INFORMATION THAT WAS RECEIVED REGARDING THE LEAD MALFUNCTION WAS FOR A DIFFERENT LEAD AND A DIFFERENT PATIENT. THERE IS NO MALFUNCTION REPORTED FOR THIS PATIENT'S RIGHT VENTRICULAR LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT TAKEN IN CLINIC HAD DECREASED FROM SIX MONTHS AGO. IT WAS ALSO REPORTED THAT THE SENSING INTEGRITY COUNT WAS HIGH, AND THAT NOISE COULD BE REPRODUCED THROUGH POCKET MANIPULATION. THE DEVICE AND LEAD ARE 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 84 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD