FDA Adverse Event
Injury
Summary report: N
UNKNOWN SPINAL CORD STIMULATOR
MDR report key: 1864491
·
Received October 6, 2010
Report
- Report Number
- 3007566237-2010-07648
- Event Type
- Injury
- Date Received
- October 6, 2010
- Report Date
- September 9, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
A PATIENT'S 4 LEADS AND AN EXTENSION WERE RETURNED TO THE MANUFACTURER. IT WAS NOTED THAT THE LEADS WERE PLACED IN THE PATIENT FOR A PERIOD OF 1 WEEK. THE REASON FOR DEVICE EXPLANT/RETURNED DEVICES WAS NOT REPORTED, NOR WAS THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SPINAL CORD STIMULATOR | LGW | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB006891V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# UNKNOWN| EXPLANTED:| LEAD: MODEL 3487A, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# UNKNOWN| IMPLANTED:| LEAD: MODEL 3487A, LOT# UNKNOWN| EXPLANTED: |