MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. NEUROMONITOR BASIC KIT; DEVICE, INTRACRANIAL PRESSURE MONITORING

Catalog Number 82-6631

Device Problem Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 09/19/2013

Event Type  malfunction  

Event Description

E-mail received from the sales rep.Informed that: "the micro sensor stopped working prematurely.After seeing icp in normal range, for 10 hours, the transducer read 'no transducer detected'.All equipment was tested and it was determined that the micro sensor failed.The ms was removed on (b)(6) when the patient was taken back to the operating room for re-implantation.I will send the ms in for evaluation and would like a written report of the findings".A second microsensor was implanted in the patient on (b)(6).E-mail received from the sales rep.Informed that: for the second microsensor; ¿the surgeon stated that the drift seemed high on this ms.Readings of icp were 6-8 during a 48 hour period and when he removed the ms reading went to -7 which he feels is an indication of the drift.The ms was zeroed appropriately in the or prior to implant.I don't have anything to return for this one".Additionally, the sales rep.Called and informed that the second microsensor was implanted on (b)(6), and explanted on (b)(6).Patient was sent home after explanting the second microsensor.The alert date for the second microsensor was (b)(4).(b)(4) 2013 please be advised that this file was submitted to the fda during (b)(6).(b)(4).

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

• Brand Name: NEUROMONITOR BASIC KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; medos s.a.; rue girardet 29; le locle 2400 ; SZ 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3790507
• MDR Text Key: 21490420
• Report Number: 1226348-2014-11545
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-6631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• 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 Age: 31 YR