SURESCAN
Report
- Report Number
- 3004209178-2021-02738
- Event Type
- Malfunction
- Date Received
- February 17, 2021
- Date of Event
- February 15, 2021
- Report Date
- March 31, 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
- WA, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: PRODUCT ID: 377645. LOT# V001341. IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD. 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.
CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 377645 LOT# V001341 IMPLANTED: (B)(6) 2005 PRODUCT TYPE LEAD 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. 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.
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.
ADDITIONAL INFORMATION RECEIVED. PATIENT RESPONDED FROM FOLLOW UP SENT AND REPORTED CIRCUMSTANCES THAT LED TO STIMULATOR WIRES HEATING WAS AFTER RECHARGING DURING THE DAY THEY NOTICED HEATING SENSATION IN LOWER BACK FROM WAIST TO SHOULDER BLADES. AT TIME INTO THE TOP OF THEIR LEGS AND FACE. WORSENING AFTER AND WHEN USING INS. PATIENT HAS NOT DONE ANYTHING TO CORRECT IT YET. APPOINTMENT IS SCHEDULED FOR (B)(6).
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT HAD BEEN USING STIM WITH THE RE-CHARGER AS THEY ALWAYS DO WHILE AT HOME. USUALLY IF SITTING AT HOME THEY USE THAT TO NOT RUN THE BATTERY DOWN AND THAT'S THE WAY THEY HAVE USED THE SYSTEM SINCE THE ORIGINAL IMPLANT IN LATE 2005. IF LYING IN BED AT NIGHT OR THEY ARE SOMEWHERE OTHER THAN AT HOME, THEY USE THE REMOTE CONTROLLER. ON THE MORNING OF (B)(6), THEY HAD BEEN USING THEIR STIM (RE-CHARGING UNIT) OFF AND ON FOR SEVERAL HOURS IN THE MORNING AND THAT AFTERNOON, THEY HAD TO GO TO AN APPOINTMENT. WHEN THEY GOT INTO THE CAR TO DRIVE THERE, THEY NOTICED THEIR ENTIRE LOWER BACK WAS VERY WARM, LIKE A CAR SEAT WARMER WAS ON, EXCEPT THEY DON'T HAVE SEAT WARMERS IN THAT CAR. THE WARMING WAS ALMOST UNCOMFORTABLY WARM, BUT BEARABLE. IT CONTINUED FOR DAYS AFTERWARDS. THE WARMTH WAS IN THE ENTIRE AREA OF WHERE THE STIMULATION COVERS, THEIR LOWER BACK, HIPS, AND A LITTLE BIT THRU THEIR BOTTOM INTO BOTH OF THE UPPER LEGS. AFTER QUITE A FEW DAYS IT FINALLY SUBSIDED AND THEN AGAIN WHEN THEY USED THE RE-CHARGER, IT DID IT AGAIN. RECENTLY, I STOPPED USING THE STIM ALTOGETHER FOR PROBABLY MORE THAN A WEEK. THEY DECIDED TO TRY IT AGAIN, USING JUST THE REMOTE CONTROLLER AND AGAIN AFTER A FEW DAYS OF NOT USING IT, IMMEDIATELY MY BACK WARMED UP ALONG WITH THE STIMULATION. THAT WAS ON (B)(6). THEY HAD USED THE SYSTEM FOR ONLY 20-30 MINUTES. AS OF (B)(6), THEIR LOWER BACK AND LEGS ARE STILL VERY WARM. THE STIM IMPLANT IS IN THEIR REAR RIGHT HIP. BECAUSE OF SHOULDER ISSUES, THEY SLEEP MOSTLY ON THE RIGHT SIDE. WHEN THEY DO THAT WITH THE STIM ON, THE WARMTH IS MUCH WARMER ON THE SIDE THEY ARE LAYING ON, BUT IT STILL COVERS THE ENTIRE AREA AS MENTIONED. THE PATIENT DIDN'T HAVE ANY UNUSUAL PHYSICAL ACTIVITY SO THERE HASN'T BEEN ANY EVENT THAT CHANGED THINGS. PATIENT WAS NOT SURE IF THIS IS CONNECTED BUT BECAUSE OF PINCHED NERVES IN NECK, THEIR DOCTOR HAD PRESCRIBED GABAPENTIN. THEY HAD BEEN USING THAT FOR MAYBE A WEEK OR TWO WHEN THIS ALL STARTED. PATIENT QUIT USING IT AFTER THE HEATING STARTED AND NOT USING IT HASN'T MADE ANY DIFFERENCE . PATIENT WAS SEEN IN HCP¿S OFFICE IN (B)(6) ON (B)(6). THEY CHECKED SOME THINGS AND SCHEDULED PATIENT TO SEE A REP. FROM MEDTRONIC ON (B)(6). THAT WAS THEN RESCHEDULED FOR (B)(6). THE PATIENT ADDED THAT IN THE LAST 9 MONTHS THEY HAVE LOST 45 POUNDS AND THEY WERE NOT SURE IF THAT WOULD AFFECT ANYTHING.
PT REPORTED TO REP THAT STARTING IN MID (B)(6) 2021, PT STARTED FEELING HEAT IN LOW BACK, BUTTOCKS AND THE BACK SIDES OF BOTH LEGS. PT TURNED OFF STIMULATION 3 DAYS AGO AND SYMPTOMS WENT AWAY. TURNED STIM BACK ON AND HEATING SENSATION RETURNED. REP ALSO STATED THAT PT REPORTED THIS HAPPENING BOTH DURING RECHARGING AND WITHOUT RECHARGING. TS SUGGESTED RUNNING IMPEDANCES TO CHECK SYSTEM THE NEXT TIME SHE IS WITH THE PATIENT AND TO CONSIDER LOOKING AT HISTORICAL VALUES AND COMPARE TO THE CURRENT VALUES. IMPORTANT TO CHECK FOR ANY MAJOR CHANGES. REP STATED PATIENT DOESN'T REMEMBER ANY EVENT THAT WOULD HAVE LED UP TO THIS.
CONTINUATION OF CONCOMITANT PRODUCTS: PRODUCT ID: 377645, LOT#: V001341, IMPLANTED: (B)(6) 2005, PRODUCT TYPE : LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377645, SERIAL/LOT #: (B)(4), UBD: 01-DEC-2009, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234649 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |