MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-01-07 for ALGOLINE 81102 manufactured by Medtronic Neuromodulation.
[132235595]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132235596]
Information was received from a healthcare provider via a clinical study regarding a patient receiving unknown drug via an implanted pump. It was reported the catheter was cut/sheared off from the insertion needle during placement surgery. The event date was noted as (b)(6) 2018. The catheter was disposed in the biohazard medical waste. No adverse event was noted and the patient recovered with no sequelae. The patient was removed from the study. Additional information received from a healthcare provider reported the cause of the catheter being cut/sheared was the physician pulled the catheter back against the needle. That patient's weight was noted as (b)(6) lbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00049 |
| MDR Report Key | 8222282 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-07 |
| 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 | 2019-01-07 |
| Model Number | 81102 |
| Catalog Number | 81102 |
| Lot Number | 27235 |
| 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 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-07 |