MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for INNERVISION SNAP SHUNT VENTRICULAR CATHETER KIT 27298 manufactured by Medtronic Neurosurgery.
[145602424]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[145602425]
It was reported the patient was prematurely delivered on (b)(6) 2017. It was stated the patient suffered a grade iv left sided intraventricular hemorrhage, giving way to hydrocephalus, which required a series of lumbar taps; a reservoir was placed (b)(6)2017. The treating neurologist planned for the patient to receive a vp shunt when they reached 2,500 grams. They fought off several serious infections before they reached that goal. Despite the setbacks, the patient gained weight and reached 2,500 grams on or about (b)(6) 2017. The treating neurologist determined that the vp shunt surgery could be performed, and the patient was implanted. According to the operative reports, the patient received a programmable valve with a snap reservoir dome. By the time several measures were taken to save the patient's life, they spiraled into metabolic acidosis and disseminated intravascular coagulopathy (dic). From the morning of the vp shunt surgery on (b)(6) 2017, until (b)(6) 2017, the patient was constantly treated for many symptoms of the massive and fatal infection. The patient died after unsuccessful cpr efforts. The cause of death was stated as cardiac arrest due to septic shock due to vp shunt infection. The autopsy report isolated the gram-negative organism in the brain, and within the catheter of the shunt as serratia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2019-00189 |
| MDR Report Key | 8625887 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-10-14 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2019-05-20 |
| 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 | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE,CA MN 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 | INNERVISION SNAP SHUNT VENTRICULAR CATHETER KIT |
| Generic Name | CATHETER, VENTRICULAR |
| Product Code | HCA |
| Date Received | 2019-05-20 |
| Model Number | 27298 |
| Catalog Number | 27298 |
| Lot Number | D3C648 |
| Device Expiration Date | 2019-03-31 |
| 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 | 1. Death | 2019-05-20 |