MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-12-28 for RESERVOIR 44111 VENTRICULAR BURR HOLE manufactured by Medtronic Neurosurgery.
[131635025]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131635026]
It was reported the patient was implanted with the reservoir in mid (b)(6) 2016. On (b)(6) 2018, the patient underwent a drug infusion. On (b)(6), the patient had a fever and was vomiting. The emergency department observed rigidity of the patient? S neck and swelling of the reservoir. Also, the patient seemed to have pain when touching the reservoir and alternate episodes of drowsiness. Grade 3 meningitis was suspected and a blood test was performed with normal result (short evolution time). A cerebrospinal fluid (csf) sample was obtained from the reservoir, which was turbid. The hospital admission was decided and intravenous antibiotic therapy with cefotaxime and vancomycin was started. On (b)(6), in the morning the patient only presented with low-grade fever. Given that the analysis of csf including gram was negative, it was decided to perform a lumbar puncture that showed cell elevation (around 1000/ml) at the expense of polymorphonuclear cells and hypoglycorrhachia. It was decided to remove the (b)(4) device by surgery on (b)(6) and the patient continued with intravenous antibiotics for approximately 15 days pending the result of the cultures. A brain nuclear magnetic resonance imaging was also performed and it did not show significant alterations or intracranial complications such as abscess or obstruction to the circulation of cerebrospinal fluid. The outcome of the event was reported as recovering/resolving. It was stated the patient's (b)(4) device and the procedural puncturing of the device may have contributed to the event. It was further stated that based on the information provided, meningitis was not suspected to be caused by the study drug.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00595 |
| MDR Report Key | 8203277 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-12-28 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2015-12-14 |
| Date Added to Maude | 2018-12-28 |
| 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 | 2018-12-28 |
| Model Number | 44111 |
| Catalog Number | 44111 |
| Lot Number | E05469 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-12-28 |