BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2964952 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02116
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 7, 2012
    Report Date
    February 27, 2013
    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
    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. (B)(4). CONCOMITANT MEDICAL PRODUCTS CONTINUED: 1599-65 (COMPETITIVE) IMPLANTABLE TACHY LEAD: (B)(6) 2002. 1488TC-52 (COMPETITIVE) IMPLANTABLE PACING LEAD: (B)(6) 2002.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE SET SCREW WAS IN THE CONNECTOR BORE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO PLACE THE "PLUG" ALL THE WAY IN TO THE "RV COIL DF-1 PORT" OF THE DEVICE. THE PHYSICIAN STATED THE SETSCREW WAS "COMPLETELY BACKED OUT" OF THE CONNECTOR. ALSO REPORTED, THE DEVICE AND LEADS WERE EXPLANTED DUE TO INFECTION AND VEGETATION; THE DEVICE WAS BEING USED AS AN EXTERNAL TEMPORARY PACEMAKER. THE LEADS WERE RETURNED; TWO OF THE EXPLANTED LEADS ARE COMPETITIVE PRODUCTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66776 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 2187-85 IMPLANTABLE PACING LEAD