BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIX

    MDR report key: 2131544 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10512
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S4
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING 15 - VENTRICULAR NST<=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 23:19:39 AND 04:21:21. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=14 COUNTS, IN 0.62 DAY, ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 01:23:07 AND 16:21:02. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED 3 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2010 AND (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD SHOWED OVERSENSING. THE LEAD WAS CAPPED 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 SUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5072 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD