FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 195554
·
Received November 3, 1998
Report
- Report Number
- 6000030-1998-00276
- Event Type
- Injury
- Date Received
- November 3, 1998
- Report Date
- October 15, 1998
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PT REPORTED EVENT OF COMA WHEN HAVING A RADIOISOTOPE STUDY OF THE DEVICE. PT STATED THAT PHYSICIAN "WAS UNAWARE OF A PIECE OF TUBING IN THE PUMP WITH BACLOFEN AND THEREFORE THE PT GOT 2 DAYS DOSE OF BACLOFEN DURING THIS STUDY." PT REPORTED HE WAS IN COMA FOR 2 DAYS AND ON A RESPIRATOR. NO REPORT OF RESIDUAL DEFICIT AND HAS BEEN ON ORAL BACLOFEN PRIOR TO PUMP REPLACEMENT. PT HAS HAD PUMP SINCE 03/1994 AND WILL HAVE A REPLACEMENT ON 10/19/1998. HAS HAD GOOD RESULTS WITH 200 MCG OF BACLOFEN INTRATHECAL PRIOR TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED Implant | IMPLANTABLE INFUSION PUMP | LKK | MEDTRONIC INC. | 8615 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization |