BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1924290 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06111
    Event Type
    Injury
    Date Received
    December 14, 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
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. ANALYSIS INDICATES THAT A POWER ON RESET (POR) OCCURRED ON (B)(6) 2010. THE POR SEVERITY IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. THE DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE EVENT. 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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATES THAT A POWER ON RESET (POR) OCCURRED ON (B)(4) 2010. THE POR SEVERITY IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. THE DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE EVENT. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RESET. DURING FOLLOW-UP THE DEVICE WAS REPROGRAMMED AND THE PHYSICIAN REQUESTED TO HAVE THE DEVICE CHANGED OUT. THE DEVICE WAS EXPLANTED AND REPLACED. 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 67 YR Hospitalization| R (B)(4) PAIN STIM IPG| 5076 (X2) IMPLANTABLE PACING LEAD| 5076 (X2) IMPLANTABLE PACING LEAD| (B)(4) PAIN STIM LEAD| (B)(4) PAIN STIM LEAD| 7489 (X2) NEURO EXTENSION| (B)(4) PAIN STIM IPG| 7489 (X2) NEURO EXTENSION