BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY SR

    MDR report key: 2123380 · Received June 14, 2011

    Report

    Report Number
    2647346-2011-00800
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4) NO ANOMALIES FOUND; THE PROXIMAL SEGMENT WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED AND BLOOD AND BODY FLUID WAS OBSERVED (NOT OBSTRUCTED). THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, COSMETIC DEPRESSION AND WAS BREACHED/CUT. THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS UPGRADED FROM A SINGLE TO A DUAL CHAMBER PACEMAKER DUE TO PACEMAKER SYNDROME. THE DEVICE WAS EXPLANTED AND REPLACED. UPON OPENING THE POCKET TO REMOVE THE DEVICE, THE RIGHT VENTRICULAR WAS CUT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODIGY SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8160 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R