BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3177476 · Received June 19, 2013

    Report

    Report Number
    3004209178-2013-10562
    Event Type
    Injury
    Date Received
    June 19, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45, LOT# V841063, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V861100, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V884579, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V884579, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THE HEALTHCARE PROVIDER (HCP) WAS GOING TO REPOSITION THE BATTERY HIGHER ON THE SAME SIDE OF THE PATIENT, BUT THE EXTENSION WIRES COULD BE ON TOP OF THE IMPLANTABLE NEUROSTIMULATOR (INS), INSTEAD OF UNDERNEATH BASED ON ANATOMY. IT WAS STATED THAT THE REASON FOR THE REVISION WAS TENDERNESS AND POSITIONING WITH EXTENSIONS CAUSED PATIENT DISCOMFORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A POCKET REVISION WITH BATTERY REPOSITIONING. THE INS WAS WORKING FINE AND THE PATIENT WAS GETTING PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277683 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention