BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3984233 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14026
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3550-39, LOT# N372854, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-39, LOT# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LESS THAN 2 WEEKS AFTER THE IMPLANT, THE PATIENT EXPERIENCED A BURNING SENSATION IN THE SIDE OF THE BACK, OPPOSITE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) LOCATION AND THE AREA WHERE THE LEADS WERE TUNNELED. THE PATIENT GOT STIMULATOR COVERAGE IN ALL AREAS THAT WERE NEEDED. IMPEDANCE TESTING AND REPROGRAMMING WERE PERFORMED. THE SYSTEM WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S OUTCOME WAS UNKNOWN AT THE TIME OF THE REPORT. IT WAS UNKNOWN IF THE BURNING SENSATION HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460958 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention