MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-11 for ALGOLINE 81102 manufactured by Medtronic Neuromodulation.
[119928172]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[119928173]
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving unknown baclofen with an unknown dose and concentration via an implantable pump for no known indication for use. It was reported the patient experienced a cerebral spinal fluid (csf) leak and a headache post catheter removal on (b)(6) 2018. It was noted that the catheter was removed and discarded in medical waste. It was stated that the temporary catheter being utilized per protocol for baclofen drug administration via bolus and withdrawal of csf. It was noted the patient received a blood patch on (b)(6) 2018. Follow up with patient reported resolution by family member on (b)(6) 2018. The event date was (b)(6) 2018 ((b)(6)). No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[133994917]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[133994918]
Additional information received from a healthcare professional (hcp) via a clinical study indicated the patient's baseline weight was (b)(6). No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-02711 |
| MDR Report Key | 7865121 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-11 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-09-11 |
| 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 | 2018-09-11 |
| 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 | 2018-09-11 |