BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1922831 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05997
    Event Type
    Injury
    Date Received
    December 13, 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
    OH, 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. EVALUATION SUMMARY: PUD231623H THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF POCKET PRESSURE IN THE MONTHS FOLLOWING A PACEMAKER TO BI-VENTRICULAR DEFIBRILLATOR CHANGE OUT. THE DEVICE WAS ALSO NOTED TO BE PRE-EROSION. THE PHYSICIAN DETERMINED THAT A POCKET REVISION WAS NEEDED. THE DEFIBRILLATOR WAS REPLACED WITH A BI-VENTRICULAR PACEMAKER DUE TO PATIENT'S AGE, CO-MORBITIES, AND THIN SIZE. 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 85 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD