BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4132853 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18093
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SINCE IMPLANT OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS), THE FELT THEY HAD AN INFECTION AND ¿IT¿S NOT HEALING¿. THE PATIENT STATED THAT WHEN THEY LEAN BACK ON THE DEVICE ¿IT HURTS AND IS UNCOMFORTABLE¿ BECAUSE IT WAS ON THEIR SPINE. THE PATIENT NOTED THAT THEY KNOW HOW TO TURN THE STIMULATION UP AND DOWN AND ¿TO MOVE IT BACK AND OVER¿ BUT DESIRED HELP WITH THE DEVICE OPERATION. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED HIS THERAPY ADJUSTED AND REPROGRAMMED. THE PATIENT STATED HE HAD A PROBLEM; BEFORE IMPLANT HE AGREED TO "A LITTLE IMPLANTABLE NEUROSTIMULATOR (INS), NON-RECHARGEABLE. HE ENDED UP WITH A BIG IMPLANT IT STICKS OUT OF HIS BACK. IT WOULD BE JUST A MATTER OF TIME WHEN IT WAS GOING TO GET CUT ON SOMETHING." IT WAS NOTED THE PATIENT NOTICED IT PRETTY MUCH RIGHT AFTER THE DEVICE WAS IMPLANTED. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THEIR HEALTHCARE PROVIDER (HCP) AND WANTED THE MANUFACTURER'S REPRESENTATIVE (REP) TO BE THERE FOR REPROGRAMMING. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING T THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN BOTHERING THE PATIENT FOR QUITE A WHILE. THE INS WAS IN A BAD SPOT AND WAS "GETTING READY TO CUT THROUGH THE SKIN." IT STARTED TO BOTHER HIM ON (B)(6) 2014. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612764 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention