FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3113645
·
Received May 15, 2013
Report
- Report Number
- 3007566237-2013-01620
- Event Type
- Injury
- Date Received
- May 15, 2013
- Report Date
- April 25, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE NUMEROUS ATTEMPTS TO GET THE IMPLANTABLE NEUROSTIMULATOR IMPLANTED. THE REPORTER STATED THAT THE PATIENT "HAD SHRAPNEL" WHERE THEY TRIED TO GET IT IN, THEY DIDN'T GET IT IN, AND THEY HAD TO LEAVE THE WIRES IN. IT WAS REPORTED THAT A DEVICE WAS ATTEMPTED TO BE IMPLANTED PERCUTANEOUSLY INSTEAD OF SURGICALLY AND ATTEMPTS AT DOING IT "COST SOME DAMAGE." 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 |
|---|---|---|---|---|---|---|---|
| 214248 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |