FDA Adverse Event
Injury
Summary report: N
SPECIFY 5X6X5 LEAD
MDR report key: 1040542
·
Received May 9, 2008
Report
- Report Number
- 2182207-2008-02526
- Event Type
- Injury
- Date Received
- May 9, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 11, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS IMPLANTED WITH 5-6-5 LEAD IN THE T9 AREA. THE FOLLOWING DAY, A POSSIBLE HEMATOMA WAS REPORTED. THE PT ALSO EXPERIENCE LOSS OF SENSATION IN LEG. THE LEAD AND EXTENSION WERE REMOVED. THE INS REMAINS IMPLANTED AND PLUGGED. HCP WOULD LIKE TO PERFORM MRI, BUT THE MANUFACTURER DOES NOT RECOMMEND WITH THE DEVICE STILL IMPLANTED. NO OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECIFY 5X6X5 LEAD | LGW | MEDTRONIC NEUROMODULATION | 39565 | N141742002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTABLE NEURO STIMULATOR MODEL 37712| EXPLANTED| EXTENSION MODEL EXTENSION| IMPLANTED| EXPLANTED| IMPLANTED |