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 2020-01-10 for CSF VENTRICULAR PORT, 16 MM, SIDE INLET 44010 manufactured by Medtronic Neurosurgery.
[188295187]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188295188]
It was reported that the patient was implanted with a reservoir on (b)(6) 2020 due to hypertensive cerebral hemorrhage. During the surgery, the connecting tube was broken, and the device was replaced.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2021898-2020-00008 |
MDR Report Key | 9574940 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-01-10 |
Date of Report | 2020-01-23 |
Date of Event | 2020-01-07 |
Date Mfgr Received | 2020-01-13 |
Device Manufacturer Date | 2017-11-02 |
Date Added to Maude | 2020-01-10 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 | CSF VENTRICULAR PORT, 16 MM, SIDE INLET |
Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
Product Code | LKG |
Date Received | 2020-01-10 |
Model Number | 44010 |
Catalog Number | 44010 |
Lot Number | E39576 |
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 | 2020-01-10 |