FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 1566219
·
Received December 17, 2009
Report
- Report Number
- 3007566237-2009-09415
- Event Type
- Injury
- Date Received
- December 17, 2009
- Date of Event
- November 30, 2009
- Report Date
- December 8, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
LITERATURE: CHAN DTM, ZHU XL, YEUNG JHM, ET AL. COMPLICATIONS OF DEEP BRAIN STIMULATION: A COLLECTIVE REVIEW. ASIAN J SURG. 2009; 32(4): 258-63. SUMMARY: THIS ARTICLE PRESENTS AN ADULT OF ALL THE PATIENT'S IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) BETWEEN 1997 TO 2008 AT ONE FACILITY TO ASSESS COMPLICATIONS ARISING FROM THE 100 DBS ELECTRODE INSERTIONS AND PREVENTION OF COMPLICATIONS. REPORTABLE EVENT: ONE PATIENT EXPERIENCED A STIMULATOR POCKET ABSCESS REQUIRING REMOVAL OF THE WHOLE SYSTEM. NO PATIENT OUTCOME WAS REPORTED. SEE LITERATURE WITH MFR REPORT # 3007566237-2009-09382.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXTENSION: MODEL UNK, LOT # UNK| EXPLANTED:| LEAD: MODEL UNK, LOT # UNK| IMPLANTED:| IMPLANTED: |