FDA Adverse Event
Other
Summary report: N
INDURA
MDR report key: 410675
·
Received August 13, 2002
Report
- Report Number
- 6000030-2002-00583
- Event Type
- Other
- Date Received
- August 13, 2002
- Date of Event
- July 19, 2002
- Report Date
- August 8, 2002
- Manufacturer
- MEDTRONIC INC
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED THE PT PRESENTED WITH SIGNS OF AN INFECTION OF THE LUMBAR REGION THAT INCLUDED REDNESS, SWELLING, AND DRAINAGE. THE ONSET OF THE INFECTION WAS APPROXIMATELY 7/17/2002. A CULTURE OF THE LUMBAR REGION WAS POSITIVE FOR MRSA. THE PT DID NOT HAVE MENINGITIS. THE PT WAS TREATED WITH IV ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. THE INFECTION RESOLVED AND THE PT HAD A BACLOFEN WITHDRAWAL SYMPTOM OF ITCHINESS. THE PT HAD RISK FACTORS OF A CHRONIC INFECTION OF OSTEOMYLITIS AND DECUBITUS ULCERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | CATHETER | LKK | MEDTRONIC INC | 8709 | J11002R24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other | PUMP MODEL #862718 IMPLANTED: 2002 EXPLANTED: 2002 |