FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1040046
·
Received May 7, 2008
Report
- Report Number
- 6000030-2008-02425
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1151-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED MOTOR WEAKNESS AND INCREASING PARALYSIS. THE HCP THOUGHT THERE WAS A POSSIBLE MASS AROUND T8 OR T9, BUT THIS NEEDED TO BE CONFIRMED BY A RADIOLOGIST. THE PUMP WAS USED TO DELIVER BACLOFEN (CONCENTRATION AND DAILY DOSE NOT REPORTED). IT WAS NOT KNOWN IF THE BACLOFEN WAS COMPOUNDED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709 | N089643010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention | EXPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863740| IMPLANTED:| LOT# (B)(6)| PROGRAMMER MODEL 8840 LOT# UNK| LOT# NGV403551H| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTABLE INFUSION PUMP MODEL 863740| IMPLANTED: |