BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2790486 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15028
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE IS PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI). WEEKLY BATTERY VOLTAGE TREND DATA IN SAVE TO DISK FILE (B)(4) SHOWS MIN BAT=2.949 TO 2.628 VOLTS BETWEEN (B)(6) 2012, WHICH IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME (RRT) OF 2.6251 VOLT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY REACH THE ELECTIVE REPLACEMENT INDICATOR [ERI] PREMATURELY. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR [LV] LEAD THRESHOLDS WERE HIGH AS THE LEAD HAD MIGRATED AFTER INITIAL IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED; THE LV LEAD 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 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD