MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY NEUROPEN; ENDOSCOPE, NEUROLOGICAL

Catalog Number UNKNOWN-ES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEUROPEN
• Type of Device: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6532064
• MDR Text Key: 74005620
• Report Number: 2021898-2017-00245
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN-ES
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 03/29/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 MO
• Patient Weight: 9