BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2201877 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03835
    Event Type
    Injury
    Date Received
    August 11, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE GROMMET WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASING NOISE. AN X-RAY WAS TAKEN WITH NORMAL RESULTS AND THE NOISE WAS UNABLE TO BE REPRODUCED IN THE CLINIC. AT A SUBSEQUENT FOLLOW-UP VISIT, IT WAS NOTED THAT OVERSENSING AND NOISE OCCURRED ON BOTH THE RV AND THE RIGHT ATRIAL (RA) LEAD WHEN PULLING DOWN ON THE DEVICE OUTSIDE THE BODY. THERE WAS NO OVERSENSING OR NOISE SEEN ON THE LEADS WHEN CHECKED WITH THE ANALYZER AND THE LEADS WERE TIGHT IN THE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU.

    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 86 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS| 5076 X2 IMPLANTABLE PACING LEADS