MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2018-04-18 for RESERVOIR 44111 VENTRICULAR BURR HOLE manufactured by Medtronic Neurosurgery.
[105849087]
Concomitant prods and therapy dates: brineura (cerliponase alfa) solution for infusion; dose 300mg, qow, icv; therapy date: unknown date. Please see report number 2021898-2018-00200 for patient's previous device issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[105849088]
On (b)(6) 2017, the patient was implanted with another ommaya reservoir. Since then, the patient continued his treatment with brineura (300 mg, qow, icv) for the indication of neuronal ceroid lipofuscinosis. On (b)(6) 2018, the patient had an asymptomatic positive culture for propionibacterium (p) acnes. As a result, the patient was not treated, device was not removed, and the patient's brineura dosing or frequency was not adjusted. Since then, the patient's subsequent csf cultures had been negative. The outcome of the event was reported as recovering/resolving. The event was assessed as related to the patient's ommaya reservoir device.
Patient Sequence No: 1, Text Type: D, B5
[134622692]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134622693]
Additional information received reported that the outcome of the event was updated to recovered/resolved on an unreported date. Concomitant medication included levetiracetam, pyridoxine and gemfibrozil. The patient's concurrent conditions included epilepsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00201 |
| MDR Report Key | 7441317 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-04-18 |
| Date of Report | 2019-01-31 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2018-04-18 |
| 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 | RESERVOIR 44111 VENTRICULAR BURR HOLE |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | JXG |
| Date Received | 2018-04-18 |
| Model Number | 44111 |
| Catalog Number | 44111 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Brand Name | RESERVOIR 44111 VENTRICULAR BURR HOLE |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2018-04-18 |
| Model Number | 44111 |
| Catalog Number | 44111 |
| Lot Number | UNKNOWN |
| 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. Other | 2018-04-18 |