MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,literature report with the FDA on 2015-03-05 for VENTRICULAR RESERVOIR ASSEMBLY, 12MM WITH BOTTOM INLET 21029 manufactured by Medtronic Neurosurgery.
[19308574]
It was discovered in a review of the literature article titled? Ventricular access device infection rate: a retrospective study and review of the literature? That a total of 142 vads were placed. There were 13 infections, 11 of which had csf-positive cultures. Once a vad infection was documented, the vad was removed within 24 hours. There were two wound complications with negative csf cultures. Six patients died after vad placement for reasons unrelated to their vad surgeries. In the remaining patients, there were 113 vad to shunt conversions.
Patient Sequence No: 1, Text Type: D, B5
[19533714]
These events were identified during a review of scientific literature. The corresponding author did not divulge specific device information or answer requests for other missing information on this medwatch report. The events in the article could not be matched to previously reported events. The products were not returned. Therefore evaluations of the device performances were not possible. Reviews of the manufacturing records were not possible as lot numbers were not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94193942]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2015-00086 |
| MDR Report Key | 4574264 |
| Report Source | 03,LITERATURE |
| Date Received | 2015-03-05 |
| Date of Report | 2015-02-03 |
| Date Mfgr Received | 2015-02-03 |
| Date Added to Maude | 2015-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 ASSEMBLY, 12MM WITH BOTTOM INLET |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | JXG |
| Date Received | 2015-03-05 |
| Catalog Number | 21029 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Brand Name | VENTRICULAR RESERVOIR ASSEMBLY, 12MM WITH BOTTOM INLET |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2015-03-05 |
| Catalog Number | 21029 |
| Lot Number | UNK |
| 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 | 2015-03-05 |