BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5188132 · Received October 29, 2015

    Report

    Report Number
    3004209178-2015-21779
    Event Type
    Injury
    Date Received
    October 29, 2015
    Report Date
    October 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S) : PRODUCT ID 3998 ,LOT# V007729, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240,SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY HAD A REACTION TO THE INTERNAL STITCHES POST IMPLANT. ONCE THE STITCHES THAT THEY PUT ON THE OUTSIDE OF THE STIMULATOR INCISION LINE FELL OFF, THE WOUND OPENED UP MORE AND MORE. IT OPENED UP ENOUGH FOR THE PATIENT TO SEE THE IMPLANTABLE NEUROSTIMULATOR (INS). THESE ISSUES OCCURRED AROUND (B)(6) 2015. THEIR DOCTOR HAD THE PATIENT DO DIFFERENT KINDS OF DRESSING AND SALINE SOLUTION. THEY ALSO GAVE THE PATIENT ANTIBIOTICS AND WERE DOING WOUND CARE "WHERE THEY GOT THE WOUND BACK ON THEM NOW." THE ISSUE HAD NOT RESOLVED AT THE TIME OF THE REPORT BUT THE WOUND CARE WAS WORKING WELL THANKS TO A WOUND VAC. THE ISSUES WERE NOTED TO BE GETTING BETTER. THE PATIENT WAS INDICATED FOR SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718051 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention