MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-03-20 for VENTRICULAR RESERVOIR, 28MM, SIDE INLET WITH VENTRICULAR CATHETER 44103 manufactured by Medtronic Neurosurgery.
[5589391]
It was reported to medtronic neurosurgery that when the csf reservoir was primed during preoperative preparation, air bubbles appeared from the reservoir. According to the report, another reservoir was used for the operation, and the operation was completed with no delay or adverse effect to the patient. The report stated that the device was discarded by the hospital.
Patient Sequence No: 1, Text Type: D, B5
[13083404]
The product was unavailable for return as it was discarded at the facility. Therefore, an evaluation of the device performance was not possible. A review of the manufacturing records showed no anomalies. The instructions for use that accompany the device caution that? Use of sharp instruments while handling these devices can nick or cut the silicone elastomer, resulting in leakage and necessitating reservoir revision. Care must be taken when closing incisions to ensure that reservoir components are not cut or nicked by suturing needles?. It is also stated that? Low tear strength is a characteristic of most silicone elastomer materials?. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94834277]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2015-00104 |
| MDR Report Key | 4620479 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-03-20 |
| Date of Report | 2015-02-19 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2015-02-19 |
| Device Manufacturer Date | 2013-07-25 |
| Date Added to Maude | 2015-04-22 |
| 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 | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| 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 | VENTRICULAR RESERVOIR, 28MM, SIDE INLET WITH VENTRICULAR CATHETER |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2015-03-20 |
| Catalog Number | 44103 |
| Lot Number | D46840 |
| Device Expiration Date | 2018-06-30 |
| 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 | 2015-03-20 |