SURESCAN
Report
- Report Number
- 3004209178-2019-02216
- Event Type
- Malfunction
- Date Received
- February 1, 2019
- Date of Event
- January 19, 2019
- Report Date
- March 13, 2019
- 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
- CA, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 FROM A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER WAS SENDING THE PATIENT TO HAVE AN X-RAY TO DETERMINE IF IT WAS INDEED A LAME LEAD AND PLANTED 18 YEARS AGO. THEY NOTED THAT THEY DID NOT HAVE THE TECHNOLOGY THAT WE HAVE TODAY AND THERE WERE NO RECENT X-RAYS. THE HEALTHCARE PROVIDER WAS GOING TO CALL THE REPRESENTATIVE WITH THE PATIENT'S NEXT FOLLOW UP APPOINTMENT. NO FURTHER COMPLICATIONS REPORTED.
DATE OF EVENT: DATE INACCURATE, ONLY THE MONTH AND YEAR ARE VALID. 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.
INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. INFORMATION WAS REPORTED THAT THE PATIENT IS GETTING POOR COMMUNICATION. THE PATIENT CANNOT TURN ON HER INS, AND THE PATIENT ALSO CANNOT GET THEIR INS TO TAKE A CHARGE. THE LAST TIME THE PATIENT HAD STIMULATION WAS A FEW WEEKS AGO (THE PATIENT WAS NOT SURE). THE PATIENT HAD CALLED BACK ONCE SHE FOUND HER PATIENT PROGRAMMER (PP), AND TRIED TO COMMUNICATE DURING THE CALL BUT SHE SAW THE POOR COMMUNICATION SCREEN. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER (HCP). ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE ON 2019-JAN-23. IT WAS REPORTED THAT THE PATIENT WAS CHARGING EVERY DAY AND THAT WAS TOO OFTEN. THE PATIENT HAD TO RECHARGE MORE FREQUENTLY IN THE LAST FEW DAYS- THE INS WOULD BE FULLY CHARGED AND BY THE NEXT DAY THE IMPLANT WAS DRAINED. RECHARGE DATA CONFIRMED THAT THE PATIENT WAS RECHARGING 4-6 HOURS DAILY. THEY RECEIVED 2-4 COUPLING BOXES DUE TO THE IMPLANT POSITION AND DEPTH. THE PATIENT'S IMPEDANCES WERE AS FOLLOWS: 2760 OHMS, 3268, 3374, 3359, 3359, 4139, 5954 OHMS. THE REPRESENTATIVE REPROGRAMMED 4 AND 5 AND THE GROUP IMPEDANCE WAS 112 OHMS, WITH JUST 6 AND 7 THE IMPEDANCE WAS 2053 OHMS. THE REPRESENTATIVE CHANGED TO REFERENCE ELECTRODE 5 AND THAT DIDN'T DETECT THE SHORT BETWEEN ELECTRODE 4 AND 5. THE REPRESENTATIVE ENDED UP USING 6 AND 7 FOR PROGRAM A2. PALPATION ALONG THE SYSTEM DIDN'T ELICIT SENSATION BUT THE PATIENT MENTIONED THAT IN CERTAIN POSITIONS THEY RECEIVED ZAPPING AND THIS WAS USUALLY WHEN THEY WERE SITTING IN THE CAR; THE SENSATION WAS ALONG THE EXTENSION/LEAD IN THE LEFT FLANK. THE PATIENT FELL FREQUENTLY. IF REPROGRAMMING DIDN'T WORK THEN SURGICAL INTERVENTION MIGHT BE NECESSARY. THE REPRESENTATIVE ALSO NOTED THAT THE PATIENT SAW A POR MESSAGE ON (B)(6) 2019 AND THE REPRESENTATIVE HELPED CLEAR THE POR AT THAT TIME. NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE REPRESENTATIVE WANTED TO KNOW IF THEY COULD RUN A LONGEVITY ESTIMATE AFTER AN OVERDISCHARGE. THE CALLER INDICATED A LEAD REPLACEMENT OUTLOOK FOR THE PATIENT DUE TO THE AGE OF THE LEAD AND THEY MIGHT REPLACE THE INS WITH A NEWER BATTERY. NO FURTHER COMPLICATIONS REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. IT WAS REPORTED THAT THERE WAS A SHORT ON ELECTRODES 4 AND 5 AND THE PATIENT WAS PROGRAMMED AROUND THESE ELECTRODES. THE PATIENT WAS STILL NOT RECEIVING SATISFACTORY STIMULATION. IT WAS NOTED THAT THEY HAD AN APPOINTMENT WITH THEIR PHYSICIAN ON (B)(6) 2019. NO FURTHER COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 91053 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |