BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2130656 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10204
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RECEIVED AND ANALYZED. THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK ON (B)(6) 2011, THE DEVICE BATTERY RRT WAS LESS THAN OR EQUAL TO 2.6251 V. THERE WAS A PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2011. THE LAST BATTERY MEASUREMENT DATA IN THE SAVE TO DISK FILE SHOWS THE BATTERY VOLTAGE AT 2.6148V ON (B)(6) 2011.

    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. EVALUATION SUMMARY FOR (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK ON (B)(6) 2011, THE DEVICE BATTERY RRT WAS LESS THAN OR EQUAL TO 2.6251 V. THERE WAS A PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2011. THE LAST BATTERY MEASUREMENT DATA IN THE SAVE TO DISK FILE SHOWS THE BATTERY VOLTAGE AT 2.6148V ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE MAY HAVE BEEN PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE PATIENT WAS 100% PACED SINCE IMPLANT AND THE DEVICE WAS PROGRAMMED TO HIGH OUTPUTS THROUGHOUT THE DEVICE LIFE DUE TO HIGH LEFT VENTRICULAR THRESHOLDS. THE DEVICE WAS REMOVED AND REPLACED AND THE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD