BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2982828 · Received February 28, 2013

    Report

    Report Number
    3007566237-2013-00625
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# VA02096, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE CAUSE OF THE INFECTION/EVENT WAS UNKNOWN. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LEAD EXPLANTED DUE TO INFECTION. IT WAS STATED THE PATIENT HAD A STAGE 1 TRIAL DONE ON (B)(6) 2013. IT WAS ALSO REPORTED THE PATIENT COMPLAINED OF FEVER AND REDNESS ON THEIR LOWER BACK THE DATE OF REPORT. THE SAME DAY, THE PATIENT HAD THEIR LEAD REMOVED AND WAS ADMITTED TO THE HOSPITAL FOR 48 HOURS AND ADMINISTERED INTRAVENOUS ANTIBIOTICS. IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER STATED THE PATIENT HAD AN INFECTION AND IT WAS UNKNOWN IF THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86190 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization