MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-31 for CSF-FLOW CONTROL SHUNT KIT, BURR HOLE 12 MM, MEDIUM PRESSURE 9040 B manufactured by Medtronic Neurosurgery.
[146933164]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146933165]
It was reported that during implant, the peritoneal catheter was blocked when the cerebrospinal fluid flowed from valve to peritoneum. The procedure was completed with backup products. The patient's status at the time of the report was alive-no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2019-00218 |
| MDR Report Key | 8660220 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-31 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2019-06-10 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2019-05-31 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| 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 | CSF-FLOW CONTROL SHUNT KIT, BURR HOLE 12 MM, MEDIUM PRESSURE |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
| Product Code | JXG |
| Date Received | 2019-05-31 |
| Model Number | 9040 B |
| Catalog Number | 9040 B |
| Lot Number | E57758 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |