BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 5480926 · Received March 4, 2016

    Report

    Report Number
    3007566237-2016-01211
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    February 1, 2008
    Report Date
    February 5, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE MONTH OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. (B)(4).

    Description of Event or Problem · 1

    SILLAY, K.A., LARSON, P.S., STARR, P.A. DEEP BRAIN STIMULATOR HARDWARE-RELATED INFECTIONS: INCIDENCE AND MANAGEMENT IN A LARGE SERIES. NEUROSURGERY. 2008; 62(2): 360-366; DISCUSSION 366-367. DOI: 10.1227/01.NEU.0000297020.60125.FC. SUMMARY: DEVICE-RELATED INFECTION IS A COMMON COMPLICATION OF DEEP BRAIN STIMULATOR (DBS) IMPLANTATION. WE REVIEWED THE INCIDENCE AND MANAGEMENT OF EARLY HARDWARE- RELATED INFECTIONS IN A LARGE SERIES. REPORTED EVENTS: A (B)(6) MAN WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED AN INFECTION AT THE CHEST LOCATION WHICH PRESENTED 23 DAYS AFTER IMPLANT, AND WAS SUCCESSFULLY TREATED WITH PARTIAL SYSTEM REMOVAL OF THE EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS). THE AUTHORS INDICATED THAT THE PATIENT PRESENTED WITH LOCALIZED SWELLING, ERYTHEMA, PURULENCE AND/OR DRAINAGE AROUND THE INS INCISION AND NOTED THAT THE CULTURE RESULTS YIELDED A ¿FEW SKIN FLORA.¿ THE PATIENT RECOVERED WITH NO CLINICAL SIGNS OF RECURRENT INFECTION AFTER 2-6 WEEKS OF INTRAVENOUSLY ADMINISTERED ANTIBIOTICS, AND SUBSEQUENTLY UNDERWENT REIMPLANTATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE SERIAL NUMBERS FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. FOLLOW-UP TO THE ARTICLE¿S CORRESPONDING AUTHOR HAS BEEN REQUESTED IN THE MASTER FILE FOR PATIENT/DEVICE INFO, EVENT DATES, AND PATIENT OUTCOMES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137819 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7424 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention