MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-04-24 for RESERVOIR 44111 VENTRICULAR BURR HOLE manufactured by Medtronic Neurosurgery.
[106736990]
Concomitant prods and therapy dates: brineura (cerliponase alfa) solution for infusion; dose: unknown, icv; therapy date: (b)(6) 2017 to unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106737311]
On an unspecified date, an ommaya 12 mm reservoir, model # 44111 was implanted. On an unspecified date in (b)(6) 2017, the patient initiated treatment with brineura (dose and frequency were not reported, icv) for the indication of neuronal ceroid lipofuscinosis. The most recent dose was administered on an unspecified date. On an unspecified date, the patient came in for an infusion. It was noted that the ommaya site looked edematous and was highly suspicious of a device leakage. A cerebrospinal fluid (csf) culture showed red blood cell (rbc) 11, white blood cell (wbc) 131, and protein 139. 2 mg/dl (units and reference range not reported). Culture showed no growth after one day. No treatment for the event was reported. The action taken with brineura due to the event was not reported. The outcome of the event was not reported. The event was assessed as related to the patient's ommaya reservoir device.
Patient Sequence No: 1, Text Type: D, B5
[108351825]
Concomitant prods and therapy dates: brineura (cerliponase alfa) solution for infusion; dose 300mg, qow, icv; therapy date: (b)(6) 2017 to unknown date. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[108351826]
Additional information received reported that on (b)(6) 2017, the patient initiated treatment with brineura (300 mg, qow). On (b)(6) 2018, at the clinic, the patient's ommaya reservoir site was noted to be soft with swelling and fluid around the area. No redness or external leakage was noted. His vital signs were within normal limits and his behavior was normal and at baseline. A neurosurgeon was consulted and the diagnosis was early pseudomeningocele around the reservoir; perhaps hydrocephalus of the communicating type or related to infusion. No action taken was with brineura due to the event. The outcome of the event was reported as recovering/resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00221 |
| MDR Report Key | 7454793 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-04-24 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-05-14 |
| Date Added to Maude | 2018-04-24 |
| 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 | LKG |
| Date Received | 2018-04-24 |
| 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 | 2018-04-24 |