SURESCAN
Report
- Report Number
- 3004209178-2018-17272
- Event Type
- Malfunction
- Date Received
- August 2, 2018
- Date of Event
- May 1, 2018
- Report Date
- September 7, 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
- RI, US
- Reporter Occupation
- OTHER
Narratives
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.
THE PATIENT REPORTED THAT THE IMPLANT HAS HURT AND BURNED THE PATIENT FOR 5 YEARS.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. TECH SUPPORT DETERMINED THROUGH IMPEDANCE TESTING THAT THE SYSTEM WAS FUNCTIONING NORMALLY. NO FURTHER INFORMATION WAS REPORTED.
INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) AND PATIENT IMPLANTED FOR SPINAL PAIN. THE PATIENT REPORTED A WARM, BURNING, AND ACHING SENSATION AT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. THEY INDICATED THAT THE ISSUE OCCURS DAILY. THERE WAS NO REPORT OF FALLS, TRAUMA, OR RECENT ENVIRONMENTAL EXPOSURES RELATED TO THE ISSUE. THE REP STATED THAT THEY TOOK IMPEDANCES AND FOUND THEM TO BE WITHIN A NORMAL RANGE OF 800-950 OHMS. THEY ALSO NOTED THAT THE SENSATION DOESN¿T GO AWAY WHEN THE PATIENT¿S STIMULATION IS TURNED OFF. THE PATIENT INDICATED THAT THE INS POCKET SITE IS NOT RED OR SWOLLEN. THE PATIENT WAS RE-DIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER. THE REP WAS MEETING WITH THE PATIENT ON THE DAY OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586395 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |