MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-17 for INNERVISION SNAP SHUNT VENTRICULAR CATHETER KIT 27298 manufactured by Medtronic Neurosurgery.
[52312750]
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. 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
[52312751]
It was reported to medtronic neurosurgery through a legal claim letter that the device had failed and the patient suffered a brain hemorrhage and permanent and debilitating injuries.
Patient Sequence No: 1, Text Type: D, B5
[94205033]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2016-00283 |
| MDR Report Key | 5882403 |
| Report Source | OTHER |
| Date Received | 2016-08-17 |
| Date of Report | 2016-07-18 |
| Date Mfgr Received | 2016-07-18 |
| Device Manufacturer Date | 2014-06-30 |
| Date Added to Maude | 2016-08-17 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BOB SHOKOOHI |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718725 |
| 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 KIT |
| Generic Name | CATHETER, VENTRICULAR |
| Product Code | HCA |
| Date Received | 2016-08-17 |
| Catalog Number | 27298 |
| Lot Number | D62266 |
| Device Expiration Date | 2019-05-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-08-17 |