MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM 46700 manufactured by Medtronic Neurosurgery.
[183373742]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183373743]
Medtronic received information that the 3-way valve cracked, leakage. The patient underwent thrombectomy treatment. The procedure was completed with backup product. The patient had hydrocephalus, subarachnoid hemorrhage.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2021898-2020-00098 |
MDR Report Key | 9829970 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-13 |
Date of Report | 2020-03-31 |
Date of Event | 2020-03-07 |
Date Mfgr Received | 2020-03-16 |
Date Added to Maude | 2020-03-13 |
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 | MGR. KATCHA TAYLOR |
Manufacturer Street | 9775 TOLEDO WAY |
Manufacturer City | IRVINE CA 92618 |
Manufacturer Country | US |
Manufacturer Postal | 92618 |
Manufacturer Phone | 7635263305 |
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 | EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM |
Generic Name | DEVICE, MONITORING, INTRACRANIAL PRESSURE |
Product Code | GWM |
Date Received | 2020-03-13 |
Model Number | 46700 |
Catalog Number | 46700 |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | N |
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. Other | 2020-03-13 |