BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1023417 · Received April 2, 2008

    Report

    Report Number
    2182207-2008-01710
    Event Type
    Injury
    Date Received
    April 2, 2008
    Report Date
    November 27, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF AN INTERNAL AUDIT, THIS REPORT IS BEING SUBMITTED. LITERATURE REFERENCE: C HAMANI, ET AL. "DEEP BRAIN STIMULATION FOR CHRONIC NEUROPATHIC PAIN: LONG-TERM OUTCOME AND THE INCIDENCE OF INSERTIONAL EFFECT. PAIN. 2006 (125) P188-196.

    Description of Event or Problem · 1

    LITERATURE REFERENCE: C HAMANI, ET AL. "DEEP BRAIN STIMULATION FOR CHRONIC NEUROPATHIC PAIN: LONG-TERM OUTCOME AND THE INCIDENCE OF INSERTIONAL EFFECT. PAIN. 2006 (125) P188-196. THE ARTICLE IS A RETROSPECTIVE ANALYSIS OF LONG-TERM RESULTS OF DEEP BRAIN STIMULATION (DBS) FOR THE TREATMENT OF NEUROPATHIC PAIN ON 21 PATIENTS. ONE PT HAD TWO CONSECUTIVE INFECTIONS REQUIRING PARTIAL REMOVAL OF THE DBS SYS AND REIMPLANTATION AFTER THE INFECTION CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention NEUROSTIMULATOR (MODEL UNK)| LEAD (MODEL 3387)| EXTENSIONS (MODEL UNK)