FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 996476
·
Received February 8, 2008
Report
- Report Number
- 2182207-2008-00625
- Event Type
- Injury
- Date Received
- February 8, 2008
- Report Date
- January 15, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
JOURNAL REFERENCE: OKAJIMA, ET AL. "EXPERIENCE OF ANESTHESIA FOR PTS WITH DEEP BRAIN STIMULATORS." MASUI 2007; 56(10): 1211-1213. THIS ARTICLE DESCRIBES A CASE REPORT OF A MALE PT, WITH DBS WHO UNDERGOES ABDOMINAL SURGERY. UPON TURNING THE DEVICE BACK ON POST-SURGERY, PARKINSON SYMPTOMS RETURN OVER THE NEXT 6 HRS. DEVICE NO LONGER SEEMED EFFECTIVE. REPORTABLE EVENT: THE AUTHOR ALSO DISCUSSED A CASE OF PERMANENT DISABILITY IN THE DEEP BRAIN CAUSED BY DIATHERMY TREATMENT WHILE TRANSFERRING HEAT TO THE LEAD CABLE. HE COMMENTS THAT DEVICE LABELING NEEDS TO ADDRESS THIS, AS IT IS NOT A PRODUCT FAILURE.
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| S | IMPLANTABLE NEUROSTIMULATOR MODEL UNK| IMPLANTABLE EXTENSION MODEL UNK |