BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1855042 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04318
    Event Type
    Injury
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. ERI (ELECTIVE REPLACEMENT INDICATOR) DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(4)-2010, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(4)-2010. HIGH BATTERY IMPEDANCE, CAUSING ERI. ANALYSIS OF THE DEVICE FOUND THE ERI IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN OBSERVED THAT THE BATTERY VOLTAGE OF AN IMPLANTED PACEMAKER AS MEASURED BY TELEMETRY WAS LOWER THAN IT SHOULD BE BASED ON THE LENGTH OF TIME THE PACEMAKER HAD BEEN IN SERVICE. THE PHYSICIAN REQUESTED THE ACTUAL NIGHT MEASUREMENT. THE PACEMAKER WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN OBSERVED THAT THE BATTERY VOLTAGE OF AN IMPLANTED PACEMAKER AS MEASURED BY TELEMETRY WAS LOWER THAN IT SHOULD BE BASED ON THE LENGTH OF TIME THE PACEMAKER HAD BEEN IN SERVICE. THE PHYSICIAN REQUESTED THE ACTUAL NIGHT MEASUREMENT. IT WAS LATER REPORTED THAT THE PACEMAKER ENTERED ELECTIVE REPLACEMENT INDICATOR (ERI) BEFORE IT 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 28 YR Hospitalization| R 4968 X2 IMPLANTABLE PACING LEADS| 4968 X2 IMPLANTABLE PACING LEAD