MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC OJEMAN CORTICAL STIMULATOR

Catalog Number OCS2

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident has not be received for eval.An investigation has been initiated based upon the reported info.

Event Description

The product was not stimulating.No other info was provided.Several attempts have been made to obtain info but to date, no new info has been received.

• Brand Name: OJEMAN CORTICAL STIMULATOR
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 3815919
• MDR Text Key: 19795614
• Report Number: 1222895-2014-00005
• Device Sequence Number: 1
• Product Code: GYC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K924226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OCS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1