BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3864174 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11316
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 27, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPEDANCES WERE ALL FOUND TO BE WITHIN NORMAL LIMITS ON 2014-(B)(6). IT WAS STATED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. IT WAS NOTED THAT NO FURTHER ACTIONS HAD BEEN TAKEN TO RESOLVE THE EVENT AND THE PATIENT WOULD REPORT ANY FURTHER OCCURRENCE. IT WAS STATED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT HAD BILATERAL WEAKNESS IN THEIR LEGS. THE REPORTER STATED THEY WERE NOT SURE WHETHER THE IMPLANTABLE NEURO STIMULATOR (INS) OR THERAPY WAS RELATED TO THE BILATERAL WEAKNESS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD EXPERIENCED POSITIONAL CHANGES IN THEIR STIMULATION AFTER HAVING LIFTED A HEAVY OBJECT. IT WAS STATED THAT THE EVENT WAS ATTRIBUTED TO THE LEAD AS THE LEAD HAD MIGRATED. IT WAS NOTED THAT THE DEVICES WOULD NOT BE RETURNED TO THE MANUFACTURER AS THE PATIENT WAS DOING WELL. IT WAS STATED THAT X-RAYS THAT WERE TAKEN ON (B)(6) 2014 HAD SHOWN THAT THE LEFT LEAD WAS MORE CAUDAL THAN IT WAS WHEN INITIALLY PLACED. IT WAS NOTED THAT THE PATIENT HAD ONE EPISODE OF DYSESTHESIA IN THE LEGS. IT WAS NOTED THAT THE PATIENT HAD NOT SUFFERED ANY INJURY OR REQUIRED HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AREA OVER THE LEFT SIDE INS POCKET FELT ¿WARM¿ IF THE PATIENT WOULD USE THE STIMULATOR ALL DAY AT HIGHER AMPLITUDES. IT WAS NOTED THAT WHEN THE PATIENT WOULD TURN OFF THE INS, HE HAD NO ISSUES DOING SO AND THE WARMTH WOULD SUBSIDE. IT WAS STATED THAT THE PATIENT DID NOT HAVE ANY PAIN OR REDNESS. IT WAS NOTED THAT THE LEAD HAD MIGRATED DOWNWARD ONE VERTEBRAL BODY. IT WAS NOTED THAT THE PATIENT¿S INS HAD BEEN REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337792 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1