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

Catalog Number 62-6631

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.

Manufacturer Narrative

(b)(4).It was previously reported that the device was returned for evaluation; however the date was omitted.This report has been updated to reflect the corrected information.The device was returned for evaluation.Scratches were found in the sensor case.The device passed all electronic, noise, linearity/hysteresis and signal drift tests.Both finished good and component level manufacturing records were reviewed.No discrepancies were found.Based on the evaluation of the device, the complaint could not be confirmed.The device functioned as intended.At present, we consider this complaint to be closed.

Manufacturer Narrative

(b)(4).It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.Upon completion of the investigation, a follow-up report will be submitted.

• 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: 7154769
• MDR Text Key: 96051271
• Report Number: 1226348-2017-11015
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup

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: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 62-6631
• Device Lot Number: 154107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 02/12/2018; 03/05/2018
• Supplement Dates FDA Received: 02/13/2018; 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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