BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2952878 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01826
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 2, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 MEDICAL PRODUCT: 419688, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4). DEVICE NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED. NO ANALYSIS COULD NOT BE PERFORMED DUE TO LEGAL RESTRICTIONS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RV LEAD WAS REPORTED CAPPED AND THE DEVICE AND LV LEAD HAVE BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT OF A LV (LEFT VENTRICULAR) LEAD, AS THE PHYSICIAN WAS REMOVING A COMPETITOR GUIDEWIRE, THE GUIDEWIRE CAME OUT OF THE LEAD ONLY SO FAR AND THEN STOPPED. THE PHYSICIAN CLIPPED THE GUIDEWIRE EVEN WITH THE CONNECTOR PIN AND, AGAINST ADVICE, ATTEMPTED TO INSERT THE PIN INTO THE DEVICE HEADER SEVERAL TIMES. THE LV PORT WAS APPARENTLY DAMAGED AS A RESULT. IT WAS ALSO NOTED THAT THE CHRONIC RV (RIGHT VENTRICULAR) LEAD'S RV DEFIBRILLATION COIL BECAME DAMAGED DURING THE PROCEDURE. THE RV LEAD HAD BEEN PREVIOUSLY STABLE OTHER THAN LOW R-WAVE MEASUREMENTS. THE RV LEAD WAS EXPLANTED AND REPLACED, AND THE LV LEAD AND DEVICE WERE NOT USED AND BOTH WERE REPLACED. NO PATIENT COMPLICATIONS HAVE EEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57114 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R "SEE H10...."| 694965 IMPLANTABLE TACHY LEAD| 694965 IMPLANTABLE TACHY LEAD