FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 229096
·
Received June 23, 1999
Report
- Report Number
- 6000030-1999-00132
- Event Type
- Malfunction
- Date Received
- June 23, 1999
- Date of Event
- April 14, 1999
- Report Date
- April 23, 1999
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH A SYNCHROMED PUMP AND CATHETER ON 5/28/1998 FOR INTRATHECAL INFUSION OF BACLOFEN FOR INTRACTABLE SPASTICITY DUE TO MULTIPLE SCLEROSIS. THE PATIENT EXPERIENCED INCREASED SPASTICITY. AN X-RAY ROTOR STUDY PERFORMED ON 4/13/1999 VERIFIED A MOTOR STALL AND ON 4/14/1999, THE PUMP WAS EXPLANTED. THE EXPLANTED PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANOTHER SYNCHROMED PUMP WAS IMPLANTED ON 4/14/1999. THE HCP STATES THE PATIENT EXHIBITS DECREASED SPASTICITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED Implant | IMPLANTABLE INFUSION PUMP | LKK | MEDTRONIC, INC. | 861718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization | 8703W INTRASPINAL CATHETER IMPLANTED 1998,| STATUS UNK. |