MAUDE Adverse Event Report: MEDTRONIC NEUROLOGICAL INNERVISION VENTRICLEAR CATHETER, BARIUM IMPREGNATED 15CM & CATHETER CONNECTOR,; EXTERNAL VENTRICULAR DRAIN

Lot Number E12802

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 10/04/2016

Event Type  Injury  

Event Description

Patient was found to have mycobacterium chelonae-abscessus group growing in culture from csf.(mycobacterium chelonae-abscessus is a waterborne organism , and healthcare associated infections may point to a contaminated source/ solutions.) placement of evds - right occipital and right frontal.

Event Description

Patient was found to have mycobacterium chelonae-abscessus group growing in culture from csf.(mycobacterium chelonae-abscessus is a waterborne organism , and healthcare associated infections may point to a contaminated source/ solutions.) placement of evds - right occipital & right frontal.

• Brand Name: INNERVISION VENTRICLEAR CATHETER, BARIUM IMPREGNATED 15CM & CATHETER CONNECTOR,
• Type of Device: EXTERNAL VENTRICULAR DRAIN
• Manufacturer (Section D): MEDTRONIC NEUROLOGICAL; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 6213579
• MDR Text Key: 63557011
• Report Number: 6213579
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2016,12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: E12802
• Other Device ID Number: IMPLANT LOG #63556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2016
• Device Age: 14 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 9