FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 801091
·
Received December 21, 2006
Report
- Report Number
- 6000030-2006-02314
- Event Type
- Malfunction
- Date Received
- December 21, 2006
- Date of Event
- September 14, 2006
- Report Date
- November 20, 2006
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS REVEALS NO ANOMALY FOUND. NORMAL DEVICE FUNCTION.
Description of Event or Problem · 1
MANUFACTURER'S REPRESENTATIVE REPORTED THE INTRATHECAL CATHETER WAS EXPLANTED AND REPLACED AFTER AN IMPLANT DURATION OF 44 MONTHS DUE TO OCCLUSION. SPECIFIC PATIENT SYMPTOMS, OR DEVICE TROUBLESHOOTING PRIOR TO REPLACEMENT SURGERY WERE NOT REPORTED. THE PATIENT WAS BEING TREATED WITH 4000MCG/ML BACLOFEN AT AN UNSPECIFIED DAILY DOSE FOR TREATMENT OF INTRACTABLE SPASTICITY DUE TO A CEREBRAL PALSY DIAGNOSIS. THE EXPLANTED CATHETER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE IMPLANTED INFUSION PUMP WAS ALSO EXPLANTED AND REPLACED DURING THE SAME SURGERY , REFER TO: MANUFACTURER REPORT NUMBER 6000030-2006-02313.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | LKK | RICE CREEK MANUFACTURING | 8711 | J11190R35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization| R | PROGRAMMER: MODEL PROGRAMMER, LOT# UNK, IMPLANTED| EXPLANTED |