BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1791342 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03109
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INDICATED SHE HAS BEEN HAVING "EXCRUCIATING PAIN AROUND THE BOX (ICD)" AND THAT THE LEFT VENTRICULAR LEAD WAS "PACING MY DIAPHRAM" AND IS "TURNED OFF". PREVIOUS EXPERIENCE ON THE DEVICE INCLUDES PATIENT REPORTING THAT SHE HAS DIAPHRAGM STIMULATION. THE DEVICE AND LEAD ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INDICATED SHE HAS BEEN HAVING "EXCRUCIATING PAIN AROUND THE BOX (ICD)" AND THAT THE LEFT VENTRICULAR (LV) LEAD WAS "PACING MY DIAPHRAM" AND IS "TURNED OFF". PREVIOUS EXPERIENCE ON THE DEVICE INCLUDES PATIENT REPORTING THAT SHE HAS DIAPHRAGM STIMULATION. IT WAS FURTHER REPORTED THAT THE LV LEAD WAS CAPPED AND DEVICE REMOVED AT THE PATIENT'S REQUEST. THE DEVICE AND LEAD WERE NOT REPLACED. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| O| R 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD