BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3212903 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11482
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3776-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. IT WAS STATED THAT THE PATIENT USED HIGH AMPLITUDE TO COVER THE PAIN AND EXPERIENCED OVERSTIMULATION WHEN LEANING BACK. IT WAS ADDED THAT HEALTHCARE PROVIDER (HCP) WANTED TO IMPLANT SENSOR TO CONTROL PATIENT LEAN BACKWARD AND CONTROL OVERSTIMULATION. IT WAS ALSO NOTED THERE WAS NO DEVICE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE OF THEIR POSTURE DUE TO BEING IN A WHEELCHAIR. SPECIFICALLY, THE PATIENT HAD ISSUES LEANING FORWARD AND BACKWARDS WITH THE DEVICE. THE INS SYSTEM WAS REMOVED AND A NEW DEVICE SYSTEM WAS IMPLANTED. AFTER ACTIVATION OF THE NEW DEVICE EVERYTHING WAS REPORTED AS "WORKING WONDERFULLY". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312977 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