MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-22 for ALGOLINE CATHETER KIT 81102 manufactured by Medtronic Neurosurgery.
[17958680]
(b)(4). The device has not been returned to the mfr. A review of the mfg records showed no anomalies.
Patient Sequence No: 1, Text Type: N, H10
[18041843]
It was reported to medtronic neurosurgery that the distal end of catheter was sheared off in the intrathecal space of a pt following catheter removal. According to the report the catheter was removed due to a leak noted after insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2011-00067 |
| MDR Report Key | 2031125 |
| Report Source | 05,06 |
| Date Received | 2011-03-22 |
| Date of Report | 2011-02-23 |
| Date of Event | 2011-02-23 |
| Date Mfgr Received | 2011-03-16 |
| Device Manufacturer Date | 2010-01-07 |
| Date Added to Maude | 2011-03-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059681546 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGOLINE CATHETER KIT |
| Product Code | MAJ |
| Date Received | 2011-03-22 |
| Model Number | NA |
| Catalog Number | 81102 |
| Lot Number | C60397 |
| ID Number | NA |
| Device Expiration Date | 2014-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-03-22 |