MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-07-19 for INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STANDARD, 6CM 27065 C manufactured by Medtronic Neurosurgery.
[80492677]
The product was unavailable for return. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records showed no anomalies. All catheters are 100% inspected at the time of manufacture. Please refer to the manufacturer report 2021898-2017-00385 for previous valve issues. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[80492678]
It was reported to medtronic neurosurgery that on (b)(6) 2017, the physician's notes showed they left the new valve at the prior setting, but the patient was noted to have hydrocephalus. Reportedly, the patient went to surgery on (b)(6) 2017 and had a ventriculoperitoneal (vp) shunt revision. The physician's operative note stated they decided to replace the valve and change the setting as well as replace the proximal catheter with another catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2017-00387 |
| MDR Report Key | 6725983 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-06-02 |
| Date Mfgr Received | 2017-06-19 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2017-07-19 |
| 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 | INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STANDARD, 6CM |
| Generic Name | CATHETER, VENTRICULAR |
| Product Code | HCA |
| Date Received | 2017-07-19 |
| Catalog Number | 27065 C |
| Lot Number | E18646 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2017-07-19 |