BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2810307 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09764
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# V588269, IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-45, LOT# V593230, IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-45, LOT# V366331, IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-45, LOT# V366331, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3550-39, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE NEUROSTIMULATOR (SERIAL# (B)(4)), EXTENSION (SERIAL# (B)(4)), AND ANCHOR REVEALED NO ANOMALIES. ANALYSIS OF THE EXTENSION (SERIAL# (B)(4)) AND LEADS (LOT#S V366331, V366331, V588269, AND V593230) REVEALED NO SIGNIFICANT ANOMALIES; ALL PRODUCTS HAD BEEN CUT DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOCATION OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNCOMFORTABLE AND THE DEVICE CAUSED HIM MORE PAIN. IT WAS ALSO REPORTED THE PATIENT'S OVERALL PAIN HAD GOTTEN WORSE AND HE NEEDED TO TAKE MORE PAIN PILLS SO THE PATIENT HAD A PUMP IMPLANTED. THE PATIENT'S INS WAS EXPLANTED AND HE RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00077 YR Required Intervention