FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3935144
·
Received July 15, 2014
Report
- Report Number
- 3007566237-2014-01960
- Event Type
- Injury
- Date Received
- July 15, 2014
- Date of Event
- May 27, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT REQUIRED A REVISION OF THEIR LEAD BECAUSE THE ¿STIMULATION WAS NOT IN THE CORRECT PLACE.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411993 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |