BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2894203 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00076
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, 355531 LOT# N293843, IMPLANTED: 2011 (B)(6), PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED FOR UPDATES TO CONCLUSION, DEVICE AND PATIENT CODING. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT PER THE PATIENT'S REQUEST, THE PATIENT'S DEVICE WAS MOVED FROM THE HIP AREA TO THE ABDOMEN ON (B)(6) 2012. REFER TO MANUFACTURER'S REPORT # 3004209178-2013-01491 FOR ADDITIONAL PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION UNDER THE IMPLANTABLE NEUROSTIMULATOR (INS) AND FELT THAT THE INS WAS REJECTING ITSELF FROM HER UPPER BUTTOCKS. THIS PAIN WAS NOTED TO "GO INTO THE PATIENT'S HIP BONE" AND AT TIMES SHE COULDN'T WALK BECAUSE OF IT. THIS PAIN AT THE INS SITE WAS INDICATED TO HAVE STARTED AT IMPLANT. THE REPORTER ALSO STATED THAT WHEN THE PATIENT CHARGED HER DEVICE, HER SKIN GOT HOT AND TURNED DARK RED. THE INS WAS ALSO NOTED TO HIT ON THINGS AND "STUCK OUT". THE PATIENT DID NOT HAVE ANY METAL ALLERGIES BUT WAS ALLERGIC TO "A LOT OF OTHER THINGS". THE DEVICE WAS INDICATED TO WORK WELL OTHERWISE. THE REPORTER STATED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) THOUGHT THAT SCAR TISSUE MAY HAVE BEEN FORMING AND STATED THAT THE SKIN OVER THE INS LOOKED TOO THIN. THE PATIENT WAS HAVING THE DEVICE MOVED TO HER ABDOMEN ON (B)(6) 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224 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