BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3973589 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13832
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    January 20, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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. 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 HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT AND OVERSTIMULATION. THE PATIENT HAD BURNS AND PAIN AS A RESULT OF A PREVIOUS MRI THAT WAS ABORTED DURING THE PROCEDURE DUE TO EXTREME PAIN. THE DOCTOR ORDERED X-RAYS ON THE SAME DAY AND SOME OTHER DIAGNOSTIC TESTS TO TROUBLE SHOOT THE PROBLEMS. IT WAS UNKNOWN WHAT THE OTHER DIAGNOSTIC TESTS WERE. IMPEDANCES WERE CHECKED AND RANGED FROM 586-824 OHMS EXCEPT FOR CONTACT 14 WHICH SHOWED > 10,000 OHMS. REPROGRAMMING WAS ATTEMPTED. DIFFERENT CONFIGURATIONS, PLACEMENTS, AND PULSE WIDTHS WERE ATTEMPTED WHICH ALL ELICITED INCREASED PAIN IN THE PATIENT¿S LOWER BACK AND RIGHT FOOT. THE PATIENT ALSO HAD STIMULATION IN THE WRONG LOCATION. THE PATIENT EXPERIENCED A BURNING SENSATION, LOSS OF REFLEXES IN THEIR LOWER EXTREMITIES, PAIN, PARALYSIS, WEAKNESS, AND LESS THAN (B)(6)% THERAPY RELIEF. THE PATIENT HAD BOWEL MOVEMENT ISSUES, A LOCKED RIGHT LEG, AND NUMBNESS AND LOSS OF SENSATION IN THEIR LEFT LEG FROM THE KNEE DOWN TO THE FOOT AT THE TIME OF THE REPORT. POST MRI THE PATIENT REPORTED BURN MARKS AROUND THE BATTERY AND SEVERE PAIN IN THE SPINE AT THE LEVEL OF THE LEADS. THE SYMPTOMS WERE PRESENT AT THE DEVICE POCKET AND THE LEAD LOCATION. THE PATIENT STATUS AT THE TIME OF THE REPORTED WAS UNKNOWN. IT WAS FURTHER REPORTED THAT THE DOCTOR WAS STILL TRYING TO DETERMINE THE CAUSE OF THE ISSUES. THEY WERE GOING TO SET UP A SERIES OF ACTIONS TO RESOLVE THE ISSUE BUT DID NOT SHARE THEIR THOUGHT PROCESS OR PLANS WITH THE MANUFACTURER REPRESENTATIVE. THE PATIENT WAS STILL EXPERIENCING THE SAME SYMPTOMS AS FAR AS THE MANUFACTURER REPRESENTATIVE KNEW. 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
    449758 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability "SEE H10...."