FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1226537
·
Received November 11, 2008
Report
- Report Number
- 2182207-2008-07348
- Event Type
- Injury
- Date Received
- November 11, 2008
- Report Date
- November 6, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS CODE = CATHETER.
Description of Event or Problem · 1
JOURNAL REFERENCE: STETKAROVA I, VRBA I, PEREGIN J, SROUBEK J. COMPLICATIONS OF TREATMENT OF SEVERE SPASTICITY WITH IMPLANTABLE PUMP SYSTEMS. CESKA SLOV NEUROL NEUROCHIR. 2008; 71(4):458-465. THE EFFECT ON INTRATHECALLY ADMINISTERED BACLOFEN WAS TESTED IN 19 PTS WITH SEVERE SPASTICITY AND IN ONE PT WITH GENERALISED DYSTONIA. BASED ON THE EFFECT OF TESTED BACLOFEN, WE SUBSEQUENTLY IMPLANTED PUMP SYSTEMS TO NINE PERSONS WITH MULTIPLE SCLEROSIS AND FIVE PERSONS WITH A CHRONIC SPINAL INJURY. REPORTABLE EVENT: IN ONE PT, A CATHETER FRACTURE OCCURRED. IN ALL THESE CASES, A SURGICAL REVISION WITH SUBSEQUENT REPLACEMENT OF THE CATHETER WAS NECESSARY. SEE MFG REPORT# 2182207200807345.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER: MODEL UNK N=1| PROGRAMMER: MODEL UNK N=1 |