BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3811357 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08983
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 9 77A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. F(B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN APPOINTMENT ON 2014-(B)(6) WITH THEIR HEALTHCARE PROFESSIONAL (HCP) TO DISCUSS EXPLANT. IT WAS NOTED THAT WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON, THE INS INCREASED THE BURNING SENSATION THE PATIENT EXPERIENCED AROUND THE INS SITE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HCP CANCELLED THE PATIENT¿S APPOINTMENT, BUT THEY PLANNED TO REFER THE PATIENT TO A SURGEON TO HAVE THE SYSTEM EXPLANT. THE REPORTER STATED THE PATIENT WOULD NOTIFY THEM WHEN THE DATE WAS SCHEDULED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE MANUFACTURER REPRESENTATIVE SPOKE WITH THE PATIENT ON (B)(6) AND THE EXPLANT HAD NOT BEEN SCHEDULED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BURNING AT THE BATTERY SITE AND THE DEVICE WAS AGGRAVATING THEIR CHRONIC PAIN. THE DEVICE WAS REPROGRAMMED AND IMPEDANCE TESTING WAS DONE. THE PATIENT WAS HAVING BURNING AND IRRITATION AROUND THEIR IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE STIMULATION WAS ON IT AGGRAVATED THE PATIENT¿S PAIN IN THAT AREA. THE SKIN AROUND THE EDGES OF THE BATTERY HAD SOME BREAKDOWN. A POCKET REVISION WAS NEEDED. THE PATIENT WAS GOING TO SHUT OFF THEIR STIMULATION FOR A PERIOD OF 2 WEEKS TO DECIDE WHETHER THEY NEEDED A POCKET REVISION OR WERE JUST GOING TO HAVE THEIR SYSTEM REMOVED. THE PATIENT HAD A BURNING SENSATION AND EROSION AT THE POCKET SITE. THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS LISTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290779 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention