FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 625747
·
Received August 10, 2005
Report
- Report Number
- 6000030-2005-01241
- Event Type
- Injury
- Date Received
- August 10, 2005
- Report Date
- August 10, 2005
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT WAS EXPERIENCING "LOSS OF EFFICACY AND WITHDRAWALS." THE PATIENT WAS TREATED WITH ORAL BACLOFEN. THE HCP DID A DYE STUDY AND DETERMINED THERE WAS A CATHETER FRACTURE, THOUGH WAS UNABLE TO GO THROUGH THE ACCESS PORT. THE DISTAL PORTION OF THE CATHETER WAS REMOVED AND REPLACED.
Description of Event or Problem · 1
THE PUMP WAS ALSO EXPLANTED ON 08/2005 ELECTIVELY AS THEY WERE ALREADY DOING A CATHETER REVISION TO DECREASE THE NUMBER OF SURGERIES FOR PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | CATH | LKK | RICE CREEK MANUFACTURING | 8709 | J0177958R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization |