SURESCAN
Report
- Report Number
- 3004209178-2018-11605
- Event Type
- Malfunction
- Date Received
- May 23, 2018
- Date of Event
- May 14, 2018
- Report Date
- October 5, 2018
- 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. 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.
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 RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE REP TOLD THE PATIENT TO GET BET TER CONNECTION WHEN CHARGING SO IT WOULDN¿T TAKE SO LONG TO CHARGE. PROGRAMMING; UTILIZED EVOLVE. CAUSE WAS REPORTED TO BE DUE TO THE PATIENT NOT HAVING GOOD CONNECTION WHEN CHARGING. ISSUE HAS BEEN RESOLVED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE BACK ISSUE WAS ADDRESSED BY A REPROGRAMMING. IT WAS REPORTED THAT ANOTHER REP MET WITH THE PATIENT ON (B)(4). IMPEDANCE WAS REPORTED TO BE NORMAL. IT WAS REPORTED THAT THE SYSTEM WORKED WELL FOR HIS LEGS BUT NOT SO MUCH FOR HIS BACK. HE USED IT ALL THE TIME BECAUSE OF THE RELIEF HE GOT IN HIS LEGS; BUT WAS HOPING FOR IMPROVED RELIEF IN HIS BACK. COVERAGE WAS VERY DIFFICULT WITH THE CURRENT LEAD PLACEMENT. IT WAS REPORTED PATIENT GOT A LOT OF ABDOMINAL STIMULATION. IT WAS REPORTED HE HAS NOT UTILIZED ANY EVOLVE SETTINGS THUS FAR, AND HAS ELECTRODES IN THE 9/10 DISK SPACE. REP STATED THEY GAVE HIM 4 NEW PROGRAMS TO TRY THAT ARE ALL BIPOLES IN THE 9/10 DISK SPACE WITH VARYING PARAMETERS (90/1000, 450/40, 450/130 ETC). PLAN IS TO START ON PROGRAM B (450/40) PARAMETER AND CYCLE THROUGH THE NEW PROGRAMS EVERY 5 DAYS IF HE DOESN'T NOTICE ANY ADDITIONAL RELIEF. RE-CALIBRATED SENSOR.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION - SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN THE HEALTHCARE PROVIDERS OFFICE ON (B)(6) AND THE C/O BATTERY GETTING HOT AND NOT GETTING LOW BACK COVERAGE. HCP OFFICE SENT AN EMAIL REQUESTING THE REP TO MEET WITH THE PATIENT TO TROUBLESHOOT SYSTEM. AN APPOINTMENT WILL BE SCHEDULED WITH THE PATIENT, DATE UNKNOWN AT THIS TIME. NO SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WOULD BE MEETING WITH THE REP ON (B)(6).
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP SPOKE TO THE PATIENT AND OFFERED TO SCHEDULE A TIME TO MEET. HOWEVER, THE PATIENT WAS OUT OF TOWN FOR THE NEXT COUPLE WEEKS AND SAID THEY WOULD CALL THE REP WHEN THEY RETURNED TO SCHEDULE AN APPOINTMENT IF THEY WERE STILL HAVING ISSUES AT THAT TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380081 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |