RESTORE SENSOR SURESCAN MRI
Report
- Report Number
- 3004209178-2014-08317
- Event Type
- Injury
- Date Received
- April 30, 2014
- Report Date
- April 8, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4)
IT WAS REPORTED THE PATIENT HAD IMPROVED SIGNIFICANTLY. IT WAS NOTED THE PATIENT WAS TO BE RELEASED FROM REHAB THE DAY AFTER REPORT. IT WAS REPORTED THE PATIENT¿S WEAKNESS WAS DUE TO A SPINAL ISCHEMIC EVENT, NOT THE STIMULATOR.
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE OF A SPINAL CORD STIMULATOR, THE PATIENT EXPERIENCED NUMBNESS AND WEAKNESS IN HER LEFT LEG UPON AWAKENING FROM SURGERY. IT WAS REPORTED THERE WAS ¿SUSPICION¿ THAT THE PATIENT EXPERIENCED ¿SOME TYPE OF SPINAL STROKE¿ DURING THE PROCEDURE. IT WAS REPORTED MORE TESTING WAS TO BE PERFORMED. IT WAS NOTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. THE PATIENT REPORTEDLY REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT. THE PATIENT¿S STATUS AT THE TIME OF THE CURRENT REPORT WAS NOTED TO BE ALIVE WITH INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS INITIAL REPORT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260123 | RESTORE SENSOR SURESCAN MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization |