MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-25 for ALGOLINE 81102 manufactured by Medtronic Neuromodulation.
[115011423]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[115011424]
Information was received from a healthcare provider via a regulatory body regarding a patient receiving unknown drug via an implanted pump. It was reported the patient was scheduled for placement of trial intrathecal catheter at cervical one. When the procedure was aborted due to difficulty encountered while attempting to pass the catheter through an arachnoid web. The catheter was withdrawn from the tuohy needle, and approximately five centimeters of the catheter was retained in the intrathecal space. The patient was to be offered other treatment options. The event of the date was sometime during the month of (b)(6) 2018. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[122531307]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2018-02212 |
| MDR Report Key | 7719603 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-25 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-07-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGOLINE |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2018-07-25 |
| Model Number | 81102 |
| Catalog Number | 81102 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-25 |