FDA Adverse Event
Injury
Summary report: N
RESTORE SENSOR
MDR report key: 2855074
·
Received December 3, 2012
Report
- Report Number
- 3004209178-2012-11095
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 6, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD INFECTION OF THE LEFT SIDE OF THE DEVICE POCKET WITH SYMPTOMS OF PAIN, REDNESS AND SWELLING. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE EXPLANTED. THE PATIENT REQUIRED HOSPITALIZATION AND THERE WERE NO INJURIES OR ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 | Required Intervention |