BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1990997 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00811
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    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, ANALYZED AND FOREIGN MATERIAL WAS FOUND ON THE DEVICE.

    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): NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD SILICONE ADHESIVE DRIPPED OVER THE SIDE OF THE PACEMAKER SHELL BETWEEN THE HEADER AND THE CASING IN THREE PLACES. THE DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD SILICONE ADHESIVE DRIPPED ON THE SIDE OF THE PACEMAKER SHELL BETWEEN THE HEADER AND THE CASING IN 3 PLACES. THE IMPLANT WAS NOT ATTEMPTED. 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 85 YR Other 5076 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD