FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1102544
·
Received August 8, 2008
Report
- Report Number
- 2182207-2008-04770
- Event Type
- Injury
- Date Received
- August 8, 2008
- Date of Event
- July 2, 2008
- Report Date
- July 9, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD ELECTRODES IMPLANTED FOR A TEST PERIOD IN 2008. TWELVE DAYS LATER, THE PATIENT EXPERIENCED STRONG PAIN IN THE AREA WHERE THE DEVICE PASSED THROUGH THE SKIN. THE PATIENT SYMPTOMS INCLUDED REDNESS, FEVER, FATIGUE, SHIVERING, STRONG NEUROPATHIC PAIN IN THE RIGHT LEG AND AN INCREASE IN CRP TO 340. THE DEVICE WAS EXPLANTED IMMEDIATELY. LAB INVESTIGATIONS REVEALED STAPHYLOCOCCUS AUREUS (OXACILLIN SENSITIVE) ON THE LEAD TIP. MRI REVEALED A STRONG EPIDURAL INFECTION AT T8/9 AND T10/11. THE PATIENT RETURNED TO SURGERY FOR A MINI LAMINECTOMY OF T8/9 AND T11/12. THE PATIENT WAS RINSED OUT WITH LAVASEPT. TWO DAYS LATER, THE CRP WAS DECREASING SLOWLY. THERE WAS NO NEUROLOGIC DEFICIT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LGW | LGW | MEDTRONIC NEUROMODULATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| ACCESSORY MODEL 3550-39 LOT# B0741227K IMPLANTED| EXPLANTED| LEAD MODEL 3877 LOT# B0844135K IMPLANTED| LEAD MODEL 3877 LOT# B0844133K IMPLANTED| EXPLANTED |