FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 3439853
·
Received October 31, 2013
Report
- Report Number
- 3004209178-2013-19938
- Event Type
- Injury
- Date Received
- October 31, 2013
- Report Date
- October 10, 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
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 399930, LOT# V000265, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
THE PATIENT WAS GOING TO HAVE AN MRI BUT IT WAS NOT RELATED TO THE DEVICE. SHE WAS GOING TO HAVE THE DEVICE TAKEN OUT AT SOME TIME AND SHE HAS BEEN SPEAKING WITH HER DOCTOR ABOUT IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 558973 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |