BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2983464 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03171
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3998 LOT# V603776, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37092 LOT# 255730001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE A FEW TIMES FOR REPROGRAMMING AND "RE-TEACHING". AT THE LAST MEETING, THE PATIENT WAS PLEASED WITH THE COVERAGE FROM THEIR IMPLANTABLE NEUROSTIMULATORS (INSS). DISCUSSIONS WITH THE HEALTHCARE PROFESSIONAL (HCP) REVEALED THAT THE PATIENT FELT THAT THE DEVICE DID NOT HELP THEIR PAIN ENOUGH AND THAT THEY HAD STOPPED USING THEM. BOTH OF THE DEVICES WERE THEN EXPLANTED AT THE REQUEST OF THE PATIENT. IT WAS NOTED THAT THE LEADS REMAINED IN PLACE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE DEVICE WORKED "FOR A WHILE" THEN IT DID NOT WORK. THE PATIENT HAD HIS DEVICE REMOVED "RECENTLY". IT WAS NOTED THAT THE DOCTOR TRIMMED THE LEADS AND "LEFT THEM IN". IT WAS CONFIRMED THAT THE MEDTRONIC REPRESENTATIVE AND THE DOCTOR WORKED WITH THE PATIENT TO MAXIMIZE EFFECTIVENESS OF THE DEVICE, BUT IT WAS ULTIMATELY DECIDED THAT THE DEVICE WOULD BE REMOVED. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. THE PATIENT HAD TWO DEVICES. REFER TO MANUFACTURER REPORT # 3004209178-2013-03170 FOR INFORMATION ON THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86265 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