FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 980807
·
Received January 16, 2008
Report
- Report Number
- 2182207-2008-00281
- Event Type
- Injury
- Date Received
- January 16, 2008
- Report Date
- October 17, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NOTE: REPORT ASSUMES REVISION HAS BEEN COMPLETED.
Description of Event or Problem · 1
JOURNAL REFERENCE: GREEN, ET AL. "DEEP BRAIN SIMULATION FOR NEUROPATHIC CEPHALALGIA." CEPHALALGIA, 2006, 26:561-567. THE ARTICLE DESCRIBES A PROSPECTIVE STUDY OF SEVEN PATIENTS WITH A VARIETY OF CEPHALALGIA IN WHOM DBS WAS USED. ALL PATIENTS HAD BEEN TREATED WITH A VARIETY OF MEDICATIONS WITHOUT SUCCESS. REPORTABLE EVENT: A PATIENT BEING TREATED FOR SEVERE, CONSTANT, STABBING PAIN AFFECTING THE PERIORBITAL AREA ON THE LEFT AND EXTENDING TO THE VERTEX, POST MULTIPLE MAXILLARY SINUS SURGERY FOR RECURRING INFECTION, EXPERIENCED PAIN ASSOCIATED WITH THE EXTENSION LEAD AND IS AWAITING REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | MHY | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R | IPG (N=2)| LEAD MODEL 3387 (N=2)| LEAD EXTENSIONS (N=1) |