BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2952124 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00084
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: (B)(4) IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2006; (B)(4) IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2006. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING IMPLANT WHEN INSERTING THE LEFT VENTRICULAR LEAD, THERE WERE SIX MISSED PACED BEATS. PACING CONTINUED WITH THE ANALYZER. ONCE ALL LEADS WERE INSERTED, THE DEVICE PACED APPROPRIATELY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56708 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R (B)(4) PACEMAKER