BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3112068 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07635
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3487A-56 LOT# V181340, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 3487A-56 LOT# V181340, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT LOST 30 POUNDS AND THE SKIN WAS IRRITATED OVER THE IMPLANT. IT WAS NOTED, THE PATIENT'S RECHARGER BELT WAS BROKEN. IT WAS LATER REPORTED THAT THE PATIENT HAD EROSION AT THE POCKET SITE. IT WAS ADDED, THE PATIENT HAD A PRESSURE ULCER AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPOSED. IT WAS STATED, THE PATIENT HAD A BURNING SENSATION AND REDNESS. IT WAS NOTED, THE PATIENT HAD THEIR POCKET SITE REVISED. IT WAS STATED, THE PATIENT'S STATUS WAS ALIVE WITH INJURY. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POCKET HAD BEEN MOVED UP SLIGHTLY TO AVOID THE PATIENT'S BELT FROM RUBBING ON THE INS (IMPLANTABLE NEUROSTIMULATOR). THE PATIENT COMPLAINED HIS POCKET WAS JUST UNDER HIS BELT LINE CAUSING IT TO BECOME IRRITATED FROM THE PRESSURE. THE HCP (HEALTH CARE PROFESSIONAL) REVISED AND MOVED THE POCKET CEPHALAD. PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE EROSION AND REDNESS AT THE DEVICE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212354 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