MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT INTEGRA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS5HND

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Event Description

The transducer attached to the evd broke off (it did not get caught on anything or get knocked).The entire set up needed to be changed by neuro surgeon up to the connection point to the drain outside the skull.Manufacturer response for transducer for ventric - to measure icp, (brand not provided) (per site reporter): manufacture rep forwarded it to the complaint's department, next we will receive an email with the reference / complaint number within 24 hours and return kit.

• Brand Name: INTEGRA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; 311 enterprise dr.; plainsboro NJ 08536
• MDR Report Key: 7372942
• MDR Text Key: 103583488
• Report Number: 7372942
• 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
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: INS5HND
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1