BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3200070 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-02165
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-33, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3888-28, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37081-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3888-33, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS EXPLANTED DUE TO AN UNKNOWN INFECTION. IT WAS INDICATED THAT PATIENT WOULD PROBABLY BE RE-IMPLANTED IN THE NEXT 6 MONTHS AFTER ANTIBIOTIC TREATMENT. IT WAS ADDED THAT PATIENT EXPERIENCED SYMPTOMS OF BURNING SENSATION AND PAIN. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297974 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention