RESTORESENSOR MRI
Report
- Report Number
- 3004209178-2015-09340
- Event Type
- Injury
- Date Received
- May 19, 2015
- Report Date
- April 29, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 977A260, SERIAL# (B)(4) IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD, PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THERE WAS IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD SITE DISCOMFORT. THERE WAS NO ALLEGED PRODUCT ISSUE. THE INS SITE HAD BECOME PAINFUL AS THE PATIENT WAS VERY SLIGHT. THE HEALTHCARE PROVIDER (HCP) MAY MOVE THE GENERATOR TO THE OTHER SIDE OF THE BODY AND RE-POCKET THE INS. ACTIONS WERE NOT YET TAKEN BUT WERE PLANNED. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT WHICH INCLUDED PAIN AT THE DEVICE POCKET AND LEAD LOCATION. IT WAS THEN REPORTED THAT THE PLAN WAS TO MOVE THE INS TO THE OTHER SIDE. THE PATIENT¿S SITUATION WAS UNCHANGED AT THAT POINT. THE OFFICE WAS ACTUALLY STILL AWAITING INSURANCE APPROVAL FOR THE REVISION. INFORMATION REGARDING THE REVISION AND PATIENT OUTCOME HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326637 | RESTORESENSOR MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |