MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2011-12-27 for CATHETER NEU_UNKNOWN_CATH manufactured by Medtronic Neuromodulation.
[2497750]
Literature: bonouvrie, l. A. , van schie, p. E. M. , becher, j. G. , van ouwerkerk, w. , j. R. , reeuwijk, a. , vermeulen, r. J. Effects of intrathecal baclofen on daily care in children with secondary generalized dystonia: a pilot study. European journal of paediatric neurology 2011. 15: 539-543. Doi: 10. 1016/j. Ejpn. 2011. 05. 003. Summary: the authors report on the effects of intrathecal baclofen (itb) therapy on patients with dystonia. Four patients, three male and one female, were evaluated both during an initial itb trial with optimal dosage and a subsequent double-blind randomized trial involving itb therapy and intrathecal placebo. Reported event: in one (b)(6) male, one previous trial treatment using an external catheter was complicated by meningitis. Additional information has been requested. A follow-up report will be sent if additional information is received.
Patient Sequence No: 1, Text Type: D, B5
[9578093]
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Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2011-09352 |
| MDR Report Key | 2389667 |
| Report Source | 01,03,05 |
| Date Received | 2011-12-27 |
| Date of Report | 2011-11-29 |
| Date Mfgr Received | 2011-11-29 |
| Date Added to Maude | 2011-12-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55431 |
| Manufacturer Country | US |
| Manufacturer Postal | 55431 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER |
| Generic Name | CATHETER, INFUSION |
| Product Code | JCY |
| Date Received | 2011-12-27 |
| Model Number | NEU_UNKNOWN_CATH |
| Catalog Number | NEU_UNKNOWN_CATH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421120 US 55421 1200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-27 |