FDA Adverse Event
Injury
Summary report: N
RESTORE SENSOR
MDR report key: 3102725
·
Received May 9, 2013
Report
- Report Number
- 3004209178-2013-07446
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- April 29, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3888-56 LOT# VA05LB7, IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 74001 LOT# N347783, IMPLANTED: 2013 (B)(6), PRODUCT TYPE ADAPTER PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS EROSION AT THE LEAD / EXTENSION SITE AND THE LEAD WAS REMOVED. THERE WERE NO PATIENT SYMPTOMS / INJURIES RELATED TO THE EVENT. IT WAS LATER REPORTED THAT THE PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202979 | 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 |