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.
[183374440]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183374441]
Medtronic received information that the bottom of the external drainage and monitoring system, collecting bag fell off. The product was damaged. The product had not contact with the patient. The patient underwent ventricular drilling drainage treatment. The procedure was completed with backup product. There were not any environmental/external/patient factors that may have led or contributed to the issue. There was not any allegation that a device related issue caused or contributed to the patient? S death/injury. The event happened in patient post procedure. Currently patient is in a coma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2020-00097 |
| MDR Report Key | 9829941 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-08 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-05-07 |
| 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 |
| Lot Number | 217395073 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-13 |