FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1222005
·
Received November 6, 2008
Report
- Report Number
- 2182207-2008-07259
- Event Type
- Injury
- Date Received
- November 6, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 6, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT DESPITE DOSE ESCALATION (UP TO 1000 MCG/DAY) THE PT CONTINUED TO HAVE INCREASED SPASTICITY. UNSPECIFIED TROUBLESHOOTING DID NOT REVEAL ANY OBVIOUS ISSUES. THE HEALTH CARE PROFESSIONAL DECIDED TO REPLACE THE ENTIRE SYSTEM. THE SPINAL PORTION OF THE CATHETER WAS LEFT INTRATHECALLY AND TIED OFF. THE REPORT INDICATED THAT THERE WAS NO PT INJURY, THE PT RECOVERED WITHOUT SEQUELAE. THE PUMP WAS USED TO DELIVER LIORESAL 2000 MCG/ML AT A DAILY RATE OF 450 MCG. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | PROGRAMMER: MODEL 8840| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731 |