FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 919960
·
Received September 27, 2007
Report
- Report Number
- 6000030-2007-03180
- Event Type
- Malfunction
- Date Received
- September 27, 2007
- Date of Event
- May 25, 2007
- Report Date
- August 29, 2007
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTS THE PT HAD BEEN EXPERIENCING INCREASED MUSCLE TONE SINCE 2007. THE PUMP WAS SCHEDULED TO BE REPLACED PROPHYLACTICALLY AS IT WAS CLOSE TO 7 YEARS OLD. DURING THE REPLACEMENT SURGERY, THE SURGEON DISCOVERED THE HUB OF THE INTRATHECAL CATHETER HAD BROKEN OFF FROM THE PUMP. BOTH THE PUMP AND CATHETER WERE REPLACED. THE PT RECOVERED WITHOUT SEQUELA. SEE MFR REPORT #6000030-2007-02748.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8711 | J0058220R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER| IMPLANTED| EXPLANTED| PUMP MODEL 8627 |