BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY SSIR

    MDR report key: 1792674 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07058
    Event Type
    Injury
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF CHEST PAIN AND "ELECTRICAL SHOCKS" FROM HIS IMPLANTABLE PULSE GENERATOR. THE PHYSICIAN CHECKED THE DEVICE AND FOUND THAT THERE WAS NO POCKET STIMULATION. THE DEVICE BATTERY WAS FOUND TO BE AT END OF LIFE. THE DEVICE WAS EXPLANTED AND 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 CLARITY SSIR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC PUERTO RICO, INC. 560 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 5071 IMPLANTABLE PACING LEAD