MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-28 for NEUROPEN UNKNOWN-ES manufactured by Medtronic Neurosurgery.
[74005620]
Additional information received reported the patient had developed a recurrent fever about a week after the placement of the external ventricular drain in the operating room. After the cerebrospinal fluid culture revealed the mycobacterium abscessus, the external ventricular drain (evd) was removed and replaced with a new evd catheter. After the replacement, the patient remained clinically stable, with no evidence of systemic infection and no new fevers. It was stated that all cultures remained negative after replacing the evd catheter. Reportedly, the hospital? S investigation did not identify any environmental source of the infection. The patient had a medical history of bilateral intraventricular hemorrhage and hydrocephalus. According to the reported information, the external drainage system was the manufacturer? S product and the evd catheter was a different manufacturer? S product. Additional information received reported that a small catheter was used. This connected to a straight connector which then attached to a regular evd catheter with the tip cut off. According to the report, the disposable neuropen may also have been a source of infection. This event had been previously reported under manufacturer report number 2021898-2016-00470. The product was unavailable for return. Therefore an evaluation of the device performance was not possible.
Patient Sequence No: 1, Text Type: N, H10
[74005621]
It was reported to medtronic neurosurgery that the patient developed an infection after the placement of the device on (b)(6) 2016. According to the report, the patient found to have mycobacterium chelonae-abscessus group growing in culture from cerebrospinal fluid.
Patient Sequence No: 1, Text Type: D, B5
[94226558]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2017-00245 |
| MDR Report Key | 6532064 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-28 |
| Date of Report | 2017-03-29 |
| Date of Event | 2016-10-04 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-28 |
| 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 | BOB SHOKOOHI |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718725 |
| 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 | NEUROPEN |
| Generic Name | ENDOSCOPE, NEUROLOGICAL |
| Product Code | GWG |
| Date Received | 2017-04-28 |
| Catalog Number | UNKNOWN-ES |
| Lot Number | UNKNOWN |
| 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. Required No Informationntervention | 2017-04-28 |