RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-06668
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- April 13, 2013
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS CORRECTED FROM CONGENITAL ANOMALY TO INTERVENTION REQUIRED.
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
ADDITIONAL INFORMATION STATED THE PATIENT HAD NOT MET WITH THEIR HEALTHCARE PROVIDER SINCE (B)(6) 2013 FOR THE REVISION. IT WAS REPORTED THE DEVICE HAD TURNED AND WAS CAUSING IRRITATION TO THE AREA, BUT HAD NOT ERODED THROUGH THE SKIN. IT WAS ALSO STATED IT WAS UNKNOWN WHY THE DEVICE WAS CAUSING THE IRRITATION. THE PATIENT'S DEVICE HAD BEEN MOVED UP DURING THE REVISION AND THE PATIENT HAD NOT CONTACTED THEIR HEALTHCARE PROVIDER SINCE THEN. IT WAS REPORTED THE PATIENT'S OUTCOME WAS UNKNOWN. IT WAS LATER REPORTED, THE PATIENT HAD BEEN LAST SEEN WITH THE HEALTHCARE PROVIDER AT THE END OF (B)(6) 2013. IT WAS REPORTED THE PATIENT STATED THAT SINCE THE REVISION THE DEVICE HAD BEEN MORE COMFORTABLE AND NOT RUBBING ON THEIR CLOTHES. IT WAS STATED NO SPOTS OF IRRITATION WERE FOUND AND THE PATIENT NO LONGER HAD PAIN NEAR THE IMPLANT. IT WAS REPORTED THE PATIENT'S THERAPY HAD BEEN WORKING WELL AND THERE WERE NO INTERVENTIONS OR TROUBLE SHOOTING NEEDED, DUE TO NO COMPLAINTS AT THE TIME OF THE VISIT.
IT WAS REPORTED THE PATIENT WAS STILL HAVING PAINS. IT WAS NOTED THE PATIENT¿S LEGS STIFFEN UP AND "THEY CAN'T RUB THEM OUT." IT WAS REPORTED THE AREA AROUND THE "BOX" WAS STILL HURTING THE PATIENT. IT WAS NOTED THE PATIENT WAS CHARGING THREE HOURS OR MORE TWICE A WEEK. IT WAS REPORTED THE PATIENT NEEDED A "BOX READJUSTMENT" WITH A MANUFACTURE REPRESENTATIVE. IT WAS FURTHER NOTED THAT IF THE PATIENT TURNED THE STIMULATION UP TOO HIGH IT HURT THEIR STOMACH. IT WAS NOTED THE PATIENT STILL HAD CONCERNS, BUT WAS MEETING WITH THEIR DOCTOR OR THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2013. IT WAS REPORTED THE PATIENT WAS ¿JUST FILLING OUT CAUSE OF TWO MORE SURGERIES.¿ THE PATIENT STATED THAT "JUST FILLING OUT CAUSE OF TWO MORE SURGERIES. IT WAS UNCLEAR IF THE TWO SURGERIES WERE RELATED TO THE DEVICE AND IF OR WHEN THEY OCCURRED.
IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2013 DUE TO THE CORNER OF THE DEVICE 'POKING OUT CAUSING PAIN.' IT WAS STATED THAT THERE WAS A 'RED SPOT' TO THE RIGHT OF THE POCKET, AT THE CREASE OF THE LEFT HIP, WHICH CAUSED PAIN. IT WAS NOTED THAT THE SPOT WAS THERE PRIOR TO THE REVISION, BUT NOT AT THE PREVIOUS IMPLANT'S LOCATION. THE DEVICE WAS STATED TO HAVE BEEN MOVED UP AND MADE PARALLEL TO THE SKIN.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT HAPPENED PRIOR TO THE DEVICE BEING REVISED. THE PATIENT GAINED WEIGHT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) STARTED COMING THROUGH THE SKIN; EROSION WAS REPORTED. THE HEALTHCARE PROVIDER (HCP) THEN "RECEDED" THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171366 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Congenital Anomaly| R |