FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 884794
·
Received July 24, 2007
Report
- Report Number
- 2182207-2007-02296
- Event Type
- Injury
- Date Received
- July 24, 2007
- Report Date
- January 10, 2007
- Manufacturer
- NEUROLOGICAL DIVISION, MEDTRONIC INC.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
MCMILLIAN, MD, ET AL. "CATHETER-ASSOCIATED MASSES IN PATIENTS RECEIVING INTRATHECAL ANALGESIC THERAPY." INTL ANESTHESIA RESEARCH SOCIETY. 2003; 96: 186-90. THE PATIENT WITH OSTEOARTHRITIS OF THE KNEE DEVELOPED A CATHETER ASSOCIATED MASS AND WAS ASYMPTOMATIC. THE MEDICATION WAS MORPHINE 70 MG/ML AT A DAILY DOSE OF 15.8 MG, WITH 0.25% BUPIVICAINE. THE DURATION OF THERAPY WAS 18 MONTHS. THE PATIENT ELECTED TO DISCONTINUE INTRATHECAL THERAPY WITH REMOVAL OF THE PUMP, LEAVING THE INTRATHECAL CATHETER IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | NEUROLOGICAL DIVISION, MEDTRONIC INC. | CATHETER | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL PUMP LOT# UNKNOWN |