BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3152513 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09025
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 4470 IMPLANTABLE PACING LEAD, (B)(6) 2005; 0185 IMPLANTABLE TACHY LEAD, (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR DAYS POST IMPLANT, THE PATIENT CALLED THE CLINIC ABOUT THE ALERTS SOUNDING EVERY COUPLE OF HOURS. INTERROGATION OF THE DEVICE INDICATED THE LEAD INTEGRITY ALERT HAD ACTIVATED DUE TO HIGH IMPEDANCE. WHEN THE DEVICE WAS REMOVED FROM THE POCKET (APPROXIMATELY A DAY LATER), IT WAS EASY TO REMOVE THE LEAD WITHOUT RETRACTING THE SET SCREW. THIS WAS ATTEMPTED A COUPLE OF TIMES WITH THE SAME RESULT. THE PHYSICIAN DECIDED A NEW DEVICE WOULD BE REQUIRED. A SECOND DEVICE WAS USED. THE LEADS WERE ATTACHED AND ONCE AGAIN THE LEAD WAS EASILY REMOVED WITHOUT RETRACTING THE SET SCREW. TECHNICAL SERVICES WERE CONSULTED ON ADVICE AS TO HOW TO TIGHTEN THE LEAD IN THE HEADER. THE RECOMMENDATION WAS TO DRAG THE LEAD PIN IN THE POCKET TO ASSIST IN INSERTION. ELECTRICAL PARAMETERS AND SECURITY OF THE CONNECTION WAS DONE AND THE SECOND DEVICE REMAINED IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253076 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R