MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-03-01 for RESERVOIR 44111 VENTRICULAR BURR HOLE manufactured by Medtronic Neurosurgery.
[101340247]
Concomitant products and therapy dates: bmn 190 (cerliponase alfa) solution for infusion (lot# l241036); dose 300mg, qow, intracisternal; therapy date: (b)(6) 2017 to unknown date. Please see report number: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101340248]
It was reported that on (b)(6) 2016, the patient initiated treatment with bmn 190 (300 mg, qow, intracisternal) with the most recent dose occurring on (b)(6) 2017. On (b)(6) 2017, the ommaya 12 mm ventriculostomy device was assessed for infusion, and csf was obtained and cultured. The patient was asymptomatic and no treatment was administered. On (b)(6)2017 (three days of culture incubation), the csf culture was tested and confirmed the growth of propionibacterium acnes. The following day, the device was again assessed and a csf sample was drawn and cultured. Five days later on (b)(6) 2017 the culture was again tested and confirmed the growth of propionibacterium acnes. Due to consecutive cultures with identical bacterium and discussions with the infectious disease physicians, it was determined that a true positive culture rather than a contaminant was obtained. However, due to the subject being asymptomatic with normal csf labs (protein, glucose, and cell count), the low bacteria count within the device, and the bacteria's delayed growth, it was determined that removing the device and administering antibiotics would be more harmful than leaving the device within the patient. It was confirmed that the event was not meningitis, but a device related event. On (b)(6) 2017, the patient had another assessment and infusion, which confirmed the csf culture was negative; however the event was considered ongoing. The health care provider (hcp) assessed the etiology of the event as not related to the bmn 190 treatment, and related to the ventriculostomy device. Please see report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00104 |
| MDR Report Key | 7307526 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2018-02-26 |
| Date Added to Maude | 2018-03-01 |
| 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 | 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 | 2018-03-01 |
| 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 | 2018-03-01 |
| Model Number | 44111 |
| Catalog Number | 44111 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-03-01 |