BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1925491 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06322
    Event Type
    Injury
    Date Received
    December 14, 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) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.61 VOLTS (V) WHILE THE DAILY BATTERY VOLTAGE MEASUREMENT WAS 2.93 V. (B)(4) THE ACTUAL DEVICE WAS 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.

    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 REVEALED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.61 VOLTS (V) WHILE THE DAILY BATTERY VOLTAGE MEASUREMENT WAS 2.93 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAVE BEEN VARYING BATTERY VOLTAGE MEASUREMENTS. IT WAS LATER REPORTED THAT THERE WAS A OBSERVATION OF IMMINENT ELECTIVE REPLACEMENT INDICATOR (ERI) DURING DEVICE INTERROGATION AND THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAVE BEEN VARYING BATTERY VOLTAGE MEASUREMENTS. THE DEVICE REMAINS 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 76 YR Hospitalization| O| R 5024M IMPLANTABLE PACING LEAD| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD