BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3915800 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08568
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    October 5, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL: ABRASION DUE TO FRICTION TO THE DEVICE CAN WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PT WAS ADMITTED TO THE HOSP FOR SEPSIS ON (B)(6) 2011. UPON REVISION, THE PT EXPIRED DUE TO VF ARREST. THE LEAD WAS EXPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39333 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention