FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1002334
·
Received February 22, 2008
Report
- Report Number
- 2182207-2008-00860
- Event Type
- Injury
- Date Received
- February 22, 2008
- Report Date
- February 18, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
JOURNAL REFERENCE: ARLE ET AL. "MOTOR CORTEX STIMULATION FOR PAIN AND MOVEMENT DISORDERS." NEUROTHERAPEUTICS 2008; 5(1): 37-49. THE STUDY INVOLVES 15 PTS (8 PAIN AND MOVEMENT DISORDERS, 4 PD, 2 ET AND 1 CORTICO-BASAL DEGENERATION), USING MOTOR CORTEX STIMULATION. THE PT CASES WERE DETAILED ALONG WITH A GENERAL REVIEW AND RESEARCH OF LITERATURE RELATIVE TO MODELING AND UNDERSTANDING THE UNDERLYING MECHANISMS OF MCS. REPORTABLE EVENT: ONE PT IN THE PD GROUP HAD AN INTRAOPERATIVE SEIZURE THAT WAS GENERATED DURING THE MOTOR MAPPING AND A FOCAL MOTOR SEIZURE 2 DAYS POST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | IMPLANTABLE LEAD MODEL UNK (1)| IMPLANTABLE STIMULATOR MODEL UNK| IMPLANTABLE EXTENSIONS MODEL UNK (2)| PROGRAMMER MODEL UNK |