BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2864964 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11448
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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). ADD'L DEVICES: 4194 IMPLANTABLE PACING LEAD (B)(6) 2010; 5076 IMPLANTABLE PACING LEAD (B)(6) 2010.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING THE DEVICE CHECKED AND AFTER THE APPOINTMENT THE PATIENT PASSED OUT AND THE DEVICE SHOCKED THE PATIENT TWELVE TIMES. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT UNDERSTOOD THAT THE PHYSICIAN WAS WORKING WITH MEDICATIONS. FOLLOW UP WAS CONDUCTED AND THE PHYSICIAN INDICATED THAT THERE WAS NO ALLEGATION AGAINST THE DEVICE PERFORMANCE OR FUNCTION. THE PATIENT HAS BEEN NON-COMPLIANT WITH MEDICATIONS AND THAT IS WHAT CAUSED THE APPROPRIATE SHOCKS FOR TACHYCARDIA. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| L 6947 IMPLANTABLE TACHY LEAD