BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2212631 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06251
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF PARKINSON'S SYMPTOMS. X-RAYS CONFIRMED A BREAK OF THE LEAD, 2-3 CM FROM THE CONNECTION WITH THE EXTENSION. IMPEDENCE READINGS CONFIRMED THE BREAK OF THE LEAD, SHOWING READINGS GREATER THAN 4,000 OHMS. THE LEAD WAS REMOVED AND REPLACED. THERE WAS NO PT INJURY. THE PT WAS NOTED TO BE "OK" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPLANTED:| LEAD: MODEL 3389, LOT# UNK| IMPLANTED: