BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4093340 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17110
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION; PRODUCT ID 74001, LOT# N270132, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER; PRODUCT ID 3487A, LOT# L51034, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WENT DEAD BECAUSE SHE WENT OUT OF TOWN FOR 3 WEEKS AND FORGOT TO BRING HER RECHARGER. WHEN THE PATIENT RETURNED, THEY TRIED TO USE THE PATIENT PROGRAMMER AND REPLACED THE BATTERIES, BUT SHE WAS NOT ABLE TO MAKE A CONNECTION. THE PATIENT HAD TO COME HOME BECAUSE SHE WAS HURTING. THE PATIENT HAD TO USE THE STIMULATION THERAPY ALL OF THE TIME. WHEN THE PATIENT LEFT, HER INS WAS FULLY CHARGED AND THEN DURING THE SECOND WEEK, THE PATIENT THOUGHT IT WASN¿T WORKING AND SHE GOT OUT THE PATIENT PROGRAMMER AND PLAYED WITH IT. SHE WAS ¿ABLE TO GET A LITTLE MORE.¿ SHE REALIZED IT WASN¿T WORKING RIGHT WHEN SHE CAME BACK. THE PATIENT SAW THE INS BATTERY LOW MESSAGE WHEN SHE SYNCED WITH THE PATIENT PROGRAMMER. WHEN THE PATIENT HOOKED UP TO THE RECHARGER, SHE SAW THE CAUTION SIGN CIRCLE WITH THE INS BATTERY LOW WITH ABOUT LESS THAN A QUARTER CHARGE SHOWING. THE PATIENT PLUGGED THE RECHARGER IN AND CHARGED IT. THE PATIENT RELOCATED THE ANTENNA AND PUSHED THE GREEN BUTTON SEVERAL TIMES TO TRY TO FIND A GOOD COUPLING. THE PATIENT REPORTED GETTING BETWEEN 2 AND 0 COUPLING BOXES FILLED IN. THE PATIENT TURNED THE ANTENNA DIAL AND WAS GETTING 8 FULL BOXES. INTERVENTIONS AND PATIENT OUTCOME WERE NOT REPORTED. FOLLOW-UP HAS BEEN REQUESTED FOR THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571665 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR