MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-21 for INDURA CATHETER 8709 * manufactured by Medtronic, Inc.
[2598772]
Patient's pump was replaced six years ago and the patient has had good results until the end of last year. Around that time, patient noted to have increased spasticity and also fluctuation time in his spasticity. The doctor suspected a malfunction in the intrathecal baclofen system and performed a dye study at that time. Per report, the dye study revealed an intact rotor function of the pump; however, they were only able to drawback very minimally from the intrathecal catheter itself, suggesting catheter failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518262 |
| MDR Report Key | 2518262 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-02-10 |
| Date of Event | 2012-02-10 |
| Report Date | 2012-02-10 |
| Date Reported to FDA | 2012-03-21 |
| Date Added to Maude | 2012-04-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDURA CATHETER |
| Generic Name | CATHETER, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2012-03-21 |
| Returned To Mfg | 2012-02-17 |
| Model Number | 8709 |
| Catalog Number | * |
| Lot Number | L59323 |
| ID Number | * |
| Device Availability | R |
| Device Age | 6 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 2210 FARADAY AVENUE SUITE 100 CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-21 |