BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5573797 · Received April 13, 2016

    Report

    Report Number
    3004209178-2016-07369
    Event Type
    Injury
    Date Received
    April 13, 2016
    Report Date
    April 13, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 309328, LOT# 0205598913, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD; PRODUCT ID 309328, LOT# 0205816370, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD; PRODUCT ID 309328, LOT# 0207155925, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 309328, LOT# 0207058122, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL, VIA THE MANUFACTURER REPRESENTATIVE, REPORTED THERE WAS AN INFECTION AND THE SYSTEM WAS REMOVED. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229538 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention