FDA Adverse Event
Injury
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 2941213
·
Received February 4, 2013
Report
- Report Number
- 3007566237-2013-00354
- Event Type
- Injury
- Date Received
- February 4, 2013
- Report Date
- November 6, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
PRODUCT ID 377745, PRODUCT TYPE: LEAD (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD WAS IMPLANTED FOR SCREENING, AND THE SCREENING SHOWED THAT STIMULATION "HAD ENOUGH THERAPY" ON THE PATIENT. THE REPORTER STATED THAT THERE WAS AN INFECTION AT THE WOUND SITE DURING SCREENING AND THE LEAD WAS EXPLANTED. IT WAS NOTED THAT THE PHYSICIAN COMMENTED THAT THE INFECTION WAS NOT RELATED TO THE IMPLANTED LEAD. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46399 | EXTERNAL NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |