RESTORE SENSOR
Report
- Report Number
- 3004209178-2016-06207
- Event Type
- Injury
- Date Received
- April 6, 2016
- Date of Event
- February 16, 2016
- Report Date
- January 24, 2017
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.
REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97791, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 97791, LOT# SERIAL# UNKNOWN, PRODUCT TYPE ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. THE CONCLUSION CODE NO LONGER APPLIES. 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 PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR DID NOT FIND ANY SIGNIFICANT ANOMALY OF THE DEVICE. ANALYSIS OF THE LEAD WITH SERIAL NUMBER (B)(4) FOUND THAT CONDUCTORS NUMBERS 8 THROUGH 15 WERE ALL BROKEN 13.1 CENTIMETERS FROM THE DISTAL END OF THE LEAD. (B)(4).
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.
THE PATIENT REPORTED VIA THE MANUFACTURER THAT THE PATIENT FELT REALLY STRONG STIMULATION, SO THE PATIENT TURNED STIMULATION DOWN. WHEN THE PATIENT ATTEMPTED TO INCREASE STIMULATION, IT WAS NOT COVERING HIS LEFT LEG; THE PATIENT HAD NOT FELT ANY STIMULATION. REPORTS ELECTRODE IMPEDANCE TESTED AT 3V: 0-7: 800-900OHMS REFERENCE 0: 8: 16137 OHMS 9: 19371 OHMS 10: 23847 OHMS 11: 27440 OHMS 12: 20527 OHMS 13: >40 K OHMS 14: 28711 OHMS 15: 22794 OHMS REFERENCE 8: 9: 31011 OHMS10: 36064 OHMS 11: 37824 OHMS 12: 32644 OHMS 13: >40 K OHMS 14: >40 K OHMS 15: 37824 OHMS REFERENCE 9: 8: 31011 OHMS 10: >40 K OHMS 11: >40 K OHMS 12: 36064 OHMS 13-15: >40K OHMS THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON. THERE WAS NO TRAUMA, FALLS OR MEDICAL PROCEDURE REPORTED THAT COULD BE RELATED TO THIS ISSUE; THERE WAS NOTHING UNUSUAL. ORIGINAL PROGRAM USING: PROGRAM 1: 8+9-10+ PROGRAM 2: 13+15- REPROGRAMMING USING 8+9-, PATIENT FELT NO STIMULATION UP TO 10.5V; USING 9+12-, PATIENT FELT NO STIMULATION UP TO 10.5V. THE RESULTS OF X-RAYS WERE INCONCLUSIVE. THE PATIENT WAS REFERRED TO NEUROSURGERY FOR A REPLACEMENT. THE INDICATION FOR THERAPY WAS CHRONIC LOW BACK PAIN AND SPINAL PAIN. 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 DEVICES WERE RETURNED ASSOCIATED WITH A COMPLAINT. ANALYSIS WAS REQUESTED. NO NEW INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208546 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention |