BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4202662 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20405
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    September 30, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT COMPLAINED OF NO STIMULATION AND A RETURN OF PAIN. THE STIMULATION WAS CHARGED AND REPROGRAMMED, AFTER WHICH, IT WAS WORKING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LET THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LEVEL GET TOO LOW. THE PATIENT HAD GONE OUT OF TOWN AND HAD NOT BROUGHT HER CHARGING EQUIPMENT WITH. ABOUT 4 DAYS PRIOR TO THE DATE OF THIS REPORT, THE PATIENT HAD NOTED THAT ¿ALL OF A SUDDEN¿ HER BACK AND LEG HURT AND, AFTER CHECKING THE INS, FOUND THAT THE INS HAD HAD NO CHARGE AT ALL. THE PATIENT HAD THEN ¿HURRIED UP AND COME HOME¿ AND HAD STARTED CHARGING THE INS. IT HAD TAKEN A ¿SUPER LONG TIME¿ TO GET THE INS TO CHARGE, BUT THE PATIENT WAS ABLE TO GET THE INS TO START CHARGING. THE PATIENT HAD BEEN CHARGING THE INS AND THE INS HAD BEEN ALMOST HALF CHARGED ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT, WHEN THE PATIENT WENT TO SLEEP. THE PATIENT HAD ATTEMPTED TO CHARGE THE INS WHILE SLEEPING, BUT THAT HADN¿T WORKED BECAUSE ¿IT¿ KEPT ¿BEEPING.¿ 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684859 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR