FDA Adverse Event
Injury
Summary report: N
RESTORE SENSOR
MDR report key: 3201981
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-11189
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- April 1, 2013
- Report Date
- June 10, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTED DEVICE RELOCATED FROM THEIR LOWER BACK TO THEIR ABDOMINAL REGION IN (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301264 | 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 | 00058 YR | Required Intervention |