FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1051096
·
Received May 22, 2008
Report
- Report Number
- 6000153-2008-02752
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- December 1, 2005
- Report Date
- April 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AT FOLLOW-UP IN THE CLINIC, THE PATIENT HAD SYMPTOMS OF DRAINAGE AND TISSUE BREAKDOWN OF THE FRONTAL SCALP INCISION SUBSEQUENT TO UNILATERAL LEAD PLACEMENT. FINDINGS FROM WOUND CULTURES OBTAINED REVEALED STAPHYLOCOCCUS AUREUS WAS THE CAUSATIVE ORGANISM AND THE LEAD WAS EXPLANTED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND THE INFECTION SUBSEQUENTLY RESOLVED. A NEW LEAD WAS SUBSEQUENTLY PLACED TEN MONTHS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3387 | J0546531V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7426| PROGRAMMER MODEL 7438 LOT# NHL012935P| EXTENSION MODEL 7482 LOT# NHU103082V| EXPLANTED:| LOT# NFW121298H |