FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 366699
·
Received December 11, 2001
Report
- Report Number
- 2182207-2001-00820
- Event Type
- Injury
- Date Received
- December 11, 2001
- Report Date
- December 10, 2001
- Manufacturer
- MEDTRONIC INC
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LITERATURE REPORT OF PATIENT REQUIRING ESCALATING DOSES OF INTRATHECAL MORPHINE. FIVE YEARS AFTER IMPLANT SUDDEN EXACERBATION OF BACK PAIN WITH INCREASED NUMBNESS AND TINGLING OF LOWER EXTREMITIES AND WEAKNESS LEFT LEG. SURGICAL REMOVAL OF LARGE MASS ATTACHED TO THE DURA AND EXPLANT OF THE MORPHINE PUMP. ORAL OPIODS WITH MODERATE TO GOOD CONTROL OF PAIN AND RECOVERY OF NEUROLOGICAL DEFECTS. ANDERSON, SUSAN R., ORBEGOZO, MAURICO, RACZ, GABOR, RAJ, P. PRITHVI, "INTRATHECAL GRANULOMA IN PATIENT RECIEVING HIGH-DOSE INTRATHECAL MORPHINE THERAPY: A REPORT OF TWO CASES" PAIN PRACTICE, VOLUME 1, NUMBER 1 2001 61-67.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55783 | SYNCHROMED | CATHETER | LKK | MEDTRONIC INC | CATHETER | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization | PUMP MODEL PUMP LOT# UNKNOWN IMPLANT: UNK| EXPLANT: UNK |