FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEAD
MDR report key: 3212842
·
Received July 9, 2013
Report
- Report Number
- 3007566237-2013-02285
- Event Type
- Injury
- Date Received
- July 9, 2013
- Report Date
- July 3, 2013
- 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
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT DEVELOPED SO MUCH EPIDURAL FIBROSIS THAT THE PLACEMENT OF TWO NEW LEADS WAS UNSUCCESSFUL. THE PATIENT WAS BEING REFERRED TO A NEUROSURGEON FOR PLACEMENT OF A PADDLE LEAD. INFORMATION WAS ORIGINALLY REPORTED IN MANUFACTURER REPORT # 3004209178-2013-04395. AFTER FURTHER REVIEW IT WAS NOTED THE TWO EVENTS SHOULD BE REPORTED SEPARATELY. REFER TO MANUFACTURER REPORT # 3007566237-2013-02284 FOR REPORT ON THE OTHER LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314430 | UNKNOWN LEAD | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Required Intervention |