MAUDE Adverse Event Report: CODMAN MICROSENSORS; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Unknown product code, udi unavailable.It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

Event Description

As reported by the customer, 2 microsensors gave incorrect data when connected to the system.There were no reports of delay or patient harm.It was reported that two implanted microsensors gave inaccurate data when connected to the system.According to the customer, the microsensors showed between 50 and 60 when they were connected to the system.The monitor and cable were changed but the issue was not resolved.When the sensor was changed, the pressure went down.The med tech reported that one sensor shows 9mmhg wrong and the other shows -22mmhg wrong.

• Brand Name: CODMAN MICROSENSORS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7154754
• MDR Text Key: 96051112
• Report Number: 1226348-2017-11016
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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