FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1192080
·
Received October 7, 2008
Report
- Report Number
- 2182207-2008-06414
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 10, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PRESENTED WITH INCREASED MUSCLE TONE IN 2008. AN X-RAY REVEALED THAT THE CATHETER TIP HAD MIGRATED OUT OF THE INTRATHECAL SPACE AND THE CATHETER HAD COILED IN SUBCUTANEOUS TISSUE. THE PATIENT WAS TREATED WITH ORAL BACLOFEN AND "TRANSIDONE". AT ABOUT SIX DAYS LATER, A CATHETER REVISION WAS PERFORMED. THE DISTAL PORTION OF THE CATHETER WAS REPLACED; THE PUMP AND PROXIMAL SEGMENT REMAINED. THE LENGTH WAS PRIMED WITH THE EXISTING MEDICATION AND WAS STARTED AT A LOWER RATE OF INFUSION OF LIORESAL AT 120 MCG/DAY. AT THE TIME OF SURGERY THE DAILY DOSE WAS AT 260 MCG/DAY. THE PATIENT OUTCOME WAS REPORTED AS "NO INJURY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| CATHETER MODEL 8598 LOT# N004589032| CATHETER MODEL 8596SC LOT# N115798006| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| IMPLANTED |