BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4140807 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18292
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) PLACEMENT AS THE INS¿S POSITION WAS UNCOMFORTABLE AND PAINFUL FOR THE PATIENT. THE INS WAS ¿KIND OF MOBILE¿ AND WOULD FREQUENTLY SHIFT. THE PATIENT HAD ASSUMED THAT THE LOCATION AT WHICH THE LEADS CONNECT WITH THE INS WAS POKING HER SKIN AS THE AREA WAS ¿CONSTANTLY SORE.¿ THE PATIENT HAD NOTICED THE ISSUES AS SOON AS SHE HAD RECOVERED FROM THE IMPLANT SURGERY AND THE SWELLING WAS GOING DOWN, WHICH WAS 4-6 WEEKS POST IMPLANT. THERE HAD BEEN A 50 PERCENT OR GREATER REDUCTION OF SYMPTOMS. A ¿BINDER¿ WAS USED TO SUPPORT THE GENERATOR. THE CAUSE OF THE EVENT HAD NOT BEEN DETERMINED BUT IT WAS NOTED TO NOT HAVE BEEN DEVICE RELATED. NO OUTCOME WAS 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
    619609 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR