FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 3013572
·
Received March 20, 2013
Report
- Report Number
- 3004209178-2013-04007
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- March 4, 2013
- 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
(B)(4)
Additional Manufacturer Narrative · 1
PRODUCT ID 377745, LOT # V009143, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT # V009838, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE POSITION OF A DEVICE WAS MOVED BY THE PATIENT'S DOCTOR. IT WAS UNCLEAR WHEN OR WHY THIS OCCURRED. 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 |
|---|---|---|---|---|---|---|---|
| 115454 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |