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 2020-03-06 for STRATA II VALVE, REGULAR 42866 manufactured by Medtronic Neurosurgery.
[182549590]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182549591]
It was reported the patient was implanted with a ventriculoperitoneal shunt. The patient developed a fever 3 days after the surgery and was treated conservatively with antibiotics but failed to achieve the expected effect. It was thought that there might be a shunt infection. The shunt was explanted, and the corresponding treatment measures would be taken according to the specific situation of the patient. The patient's status at the time of the report was alive - with injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2020-00084 |
| MDR Report Key | 9799983 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2020-03-06 |
| 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 | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| 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 | STRATA II VALVE, REGULAR |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
| Product Code | JXG |
| Date Received | 2020-03-06 |
| Model Number | 42866 |
| Catalog Number | 42866 |
| Lot Number | E47047 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-06 |