BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 8379134 · Received February 28, 2019

    Report

    Report Number
    3004209178-2019-04253
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    May 28, 2009
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-45, LOT# V192499, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 3888-45, LOT# V169991, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 3888-45, LOT# V195021, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2019-FEB-27, (B)(4) (CON): INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF OTHER PAIN INDICATIONS ¿ OTHER. IT WAS REPORTED THAT THE PATIENT HAD THE INS REMOVED BECAUSE IT WAS NOT HELPING WITH THEIR PAIN. IT WAS REPORTED THAT AFTER THE PATIENT¿S SURGERY PAIN WENT AWAY, THEY NEVER HAD THERAPEUTIC RELIEF. THE PATIENT REPORTED THAT THE SYSTEM WAS EXPLANTED IN 2014 AND SOME FRAGMENTS OF THE WIRES WERE LEFT IN THEIR BODY. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174004 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention