BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3912027 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12481
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97791, LOT# N452872, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THEIR POST-OP VISIT WITH THEIR DOCTOR WITH THE COMPLAINT OF TENDERNESS, REDNESS, AND DRAINAGE FROM THE MIDLINE INCISION WHERE THE LEAD COMPONENT OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED. THE PATIENT STATED THAT THEY SPOKE WITH THE DOCTOR¿S NURSE A FEW WEEKS AGO AND WAS TOLD TO LEAVE IT OPEN TO THE AIR AND NOT APPLY ANTIBIOTIC OINTMENT. TODAY, THE DOCTOR PRESCRIBED AN ANTIBIOTIC FOR THE PATIENT AND INSTRUCTED THEM TO USE ANTIBIOTIC OINTMENT ON THE INCISIONS AND COVER WITH A DRESSING. IT WAS NOTED THAT THE PATIENT HAD AN INFECTION OF AN UNKNOWN TYPE AT THE LOCATION OF THE LEAD. NO CULTURES WERE TAKEN. THE PATIENT DENIED ANY FEVER OR CHILLS. THE PATIENT WAS TO MAKE A FOLLOW UP APPOINTMENT WITH THEIR DOCTOR IN THE NEXT COUPLE OF DAYS FOR WOUND EVALUATION. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390743 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention