FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1374344
·
Received May 4, 2009
Report
- Report Number
- 2182207-2009-03114
- Event Type
- Injury
- Date Received
- May 4, 2009
- Date of Event
- May 1, 2009
- Report Date
- April 13, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
LITERATURE: VAN RJIN MA, MUNTS AG, MARINUS J, ET AL. INTRATHECAL BACLOFEN FOR DYSTONIA OF COMPLEX REGIONAL PAIN SYNDROME. PAIN. 2009;143(1-2):41-47. SUMMARY: THIS STUDY LOOKED AT THE EFFICACY OF INTRATHECAL BACLOFEN (ITB) IN PATIENTS WITH COMPLEX REGIONAL PAIN SYNDROME (CRPS)-RELATED DYSTONIA AND TO EVALUATE IF ITB IS EFFECTIVE AND SAFE IN THIS POPULATION OVER A 12-MONTH PERIOD. FIFTY-SEVEN CRPS PATIENTS WERE ASSESSED FOR ELIGIBILITY BETWEEN JANUARY 2002 AND JANUARY 2007, 42 PATIENTS WERE ELIGIBLE TO PARTICIPATE. AFTER PUMP IMPLANT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED REFRACTORY PAIN AT THE PUMP SITE WHICH LED TO THE EXPLANTATION OF THE DEVICE. SEE MANUFACTURER REPORT NUMBER: 2182207200903083.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL CATHETER |