FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 3003956
·
Received March 14, 2013
Report
- Report Number
- 3004209178-2013-03705
- Event Type
- Injury
- Date Received
- March 14, 2013
- Report Date
- February 26, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEVICE COMPLICATIONS AND PAIN, A BURNING SENSATION, AND SWELLING AT THE RIGHT SIDE DEVICE POCKET. THE DEVICES WERE ENTIRELY REMOVED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AT THE TIME OF REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107008 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |