BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 11739458 · Received April 28, 2021

    Report

    Report Number
    3004209178-2021-06848
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    January 1, 2016
    Report Date
    April 30, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND IT WAS REPORTED THAT THERE WAS A DEVICE CONCERN AND THERE WAS NO CHANGE IN THERAPY. 2016 THEY CHANGED THE LEADS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V433259, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2016. PRODUCT TYPE: LEAD, PRODUCT ID 3888-45, LOT# V760959, IMPLANTED: (B)(6) 2011 EXPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3888-56, SERIAL/LOT #: (B)(4), UBD: 11-MAR-2014, UDI#: (B)(4); PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 23-JUN-2015, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PT SAID IN 2016 THEY HAD TO GO TO A PLASTIC SURGEON TO TAKE CARE OF SOME "TENTING" OF THEIR WIRES. PT SAID A MANUFACTURING REPRESENTATIVE (REP) WAS IN THE OPERATING ROOM TO MAKE SURE THE WIRES WERE CONNECTED PROPERLY. PT THEN SAID THEY NEVER USED INS AGAIN. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT NOTED THE INS WAS ON THE RIGHT SIDE OF THEIR BACK AND "IT SHIFTS", AS PT SAID THEY MUST HAVE SO MUCH SCAR TISSUE IN THERE FROM THE PREVIOUS SURGERIES WHERE INS WAS REPLACED AFTER RUNNING OUT OF BATTERY. IT WAS REPORTED THAT INS WAS BOTHERING THEM. PT CLARIFIED THE INS HURT AND SAID IT WAS "STICKING ME THROUGH THE SKIN". PT SAID SOMETIMES THEY DIDN'T NOTICE IT, BUT OTHER TIMES WHEN SITTING DOWN THE INS WAS REALLY UNCOMFORTABLE, AND WOULD BE HARD TO SLEEP ON THEIR RIGHT SIDE. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT DOES NOT KNOW THE CAUSE. THE PATIENT HAD NOT CHANGED HER ACTIVITY LEVELS OR HER PROGRAMMING. PT STATED THAT THERE WERE NO OTHER FACTORS THAT 2) WHAT STEPS WERE TAKEN - PT HAD TO HAVE PLASTIC SURGERY 4-5 YEARS AGO...MEDTRONIC WAS STANDING BY FOR THE PROCEDURE. THE PROCEDURE WAS URGENT HAS THE TENTING ISSUE BEEN RESOLVED BY THE PLASTIC SURGEON. THE PATIENT'S INS IS CURRENTLY DEAD AND CANNOT BE RESTARTED. PT STATED IT HAS BECOME PAINFUL IN HER BACK IT IS DIFFICULT FOR HER TO SIT UPRIGHT IN A CHAIR THAT IS NOT UPHOLSTERED. PT CANNOT SLEEP ON HER RIGHT SIDE. PT HAS AN APPT WITH A SURGEON ON THURSDAY (B)(6) 2021 TO DISCUSS REMOVING THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633329 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention "SEE H10...."