FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 920865
·
Received September 21, 2007
Report
- Report Number
- 2182207-2007-03028
- Event Type
- Injury
- Date Received
- September 21, 2007
- Report Date
- May 23, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED.
Description of Event or Problem · 1
JOURNAL REFERENCE: DIEDRICH, MD. ET AL. "EFFICIENT INTERNAL PALLIDAL STIMULATION IN GILLES DE LA TOURETTE SYNDROME: A CASE REPORT." MOVEMENT DISORDER SOCIETY. 2005; VOL. 20 NO.11: 1496-1499. THE ARTICLE LISTS INFORMATION SUGGESTING MALE PATIENT WITH GTS AND BEING TREATED WITH DEEP BRAIN STIMULATION (DBS) EXPERIENCED A NON-MASS OCCUPYING HEMOTOMA AT THE TIP OF THE DBS LEAD (RIGHT SIDE). THE HEMATOMA WAS OBSERVED BY MRI POST-OPERATIVELY. IN ADDITION, THE PATIENT DEVELOPED ALTERNATING PRONATION AND SUPINATION MOVEMENTS OF THE LEFT EXTREMITIES. THIS SIDE EFFECT WAS PERMANENT BUT WELL TOLERATED AND WAS REDUCED WITH THE STIMULATOR OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | 3389 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |