BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2781201 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09076
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 12, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_SILICONE ANCHOR, EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO ANOMALIES. ANALYSIS OF BOTH OF THE LEADS (SERIAL #'S (B)(4), (B)(4)) FOUND THAT THEY HAD BOTH BEEN SEGMENTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED BECAUSE HE NEEDED AN MRI AND DID NOT NEED THERAPY. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS GOING TO HAVE A FULL SYSTEM EXPLANT. STIMULATION WAS MAKING THE PATIENT FEELS WORSE AND WAS NOT PROVIDING THERAPEUTIC EFFECT. THE PATIENT STATED "IT JUST ISN'T HELPING LIKE IT DID AND I JUST WANT IT OUT." THE PROCEDURE WAS SCHEDULED FOR 2012 (B)(6). THE DEVICES WOULD BE SENT TO THE MANUFACTURER WHEN EXPLANTED.

    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 Required Intervention