INDURA CATHETER Adverse Event — Malfunction (MDR 2182207-2008-00766)
INDURA CATHETER Adverse Event — Malfunction (MDR 2182207-2008-00766) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INDURA CATHETER; Manufacturer: NEUROLOGICAL DIVISION, MEDTRONIC, INC.; Report number: 2182207-2008-00766.
| Device | INDURA CATHETER |
|---|---|
| Manufacturer | NEUROLOGICAL DIVISION, MEDTRONIC, INC. |
| Report number | 2182207-2008-00766 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional |
| Narrative | THE HCP REPORTED THAT THE PT WAS VERY SPASTIC AND NOT GETTING GOOD RELIEF. THE HCP REPORTED THAT THE PT HAD RELIEF OF SYMPTOMS DURING TRIAL WITH A 50 MCG BOLUS. THE INITIAL DOSING WAS 50 MCG/DAY OF 500 MCG/ML. THE DOSE WAS SLOWLY TITRATED TO 365 MCG/DAY. ESTIMATED RESERVOIR VOLUME WAS 3.2 ML; ACTUAL RESERVOIR VOLUME WAS 24 ML. DYE STUDY INDICATED KINKED CATHETER - DATE UNK. A CATHETER REVISION WAS |
| Source | openFDA MAUDE (device adverse events) |
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