BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTION AFM

    MDR report key: 2203742 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01460
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S3
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED. THE PULSE GENERATOR WAS REPROGRAMMED AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING MULTIPLE VENTRICULAR FIBRILLATION (VF) ARRESTS. THE PATIENT WAS EXTERNALLY DEFIBRILLATED AND THE PULSE GENERATOR EXPERIENCED A POWER ON RESET. DURING THE PATIENT'S LENGTHY HOSPITAL STAY THE PATIENT'S PULSE GENERATOR WAS UPGRADED TO AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THERE WAS NO CONCERN THAT THE PULSE GENERATOR CONTRIBUTED TO THE VF ARRESTS. 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 SELECTION AFM IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 902 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD