FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1032362
·
Received April 22, 2008
Report
- Report Number
- 2182207-2008-02126
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- January 1, 2005
- Report Date
- May 11, 2005
- Manufacturer
- MEDTRONIC INC., NEUROLOGICAL DIVISION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. THE CATHETER WAS RECEIVED IN TWO PIECES; PROXIMAL PIECE 3.8 CM AND 8575 PUMP CONNECTOR, DISTAL SEGMENT 80.5 CM TO DISTAL TIP. THE DISTAL SEGMENT OF THE CATHETER HAD A HOLE 37.6 CM FROM THE DISTAL TIP WHICH WAS CONSISTENT WITH EXPLANT DAMAGE.
Description of Event or Problem · 1
FOLLOWING CATHETER REPLACEMENT SURGERY, INCREASING DOSES OF ITB WERE STILL NOT WORKING. SIDE PORT ASPIRATION REVEALED NO FLOW. THE PATIENT WAS SENT BACK AGAIN TO SURGERY FOR EXCISION. THE PATIENT WAS VERY ILL WITH LIVER FAILURE DUE TO HEPATITIS C. THE SURGEON WAS RELUCTANT TO REPAIR DUE TO SEVERE COAGULOPATHY. REFERENCE MANUFACTURER REPORT # 6000030-2008-02127.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | MEDTRONIC INC., NEUROLOGICAL DIVISION | 8709AA | N001207010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |