MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. 8ROHS MICROSENSOR W/SINGLE LUMEN PLASTIC BOLT (ADULT & PEDIATRIC); DEVICE, INTRACRANIAL PRESSURE MONITORING

Catalog Number 62-6632

Device Problems Product Quality Problem (1506); Erratic Results (4059)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Gtin: (b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

This is a general complaint regarding icp express.The customer has filed a report to the swedish medical products agency regarding this product after several incidents where esd has led to malfunction or not correct recordings of icp and resulting in patient intervention.Events occurred after surgery, no delays.Problem to measure intra cranial pressure (icp) with codman icp express stop to function, often in connection with bedside xray examination.This has been going on for some time now.The most common error is that the gauges clearly is completely knocked out due to esd, and is not displaying any measured values, only an error code.It has also been the case that icp-value increase unjustifiably much, and then rather quickly returns to what could be interpreted to a normal measurement.But there have been some microsensors which after removal displayed an abnormally large drift.If that is the same microsensor as above has not been able to verify, but there is a factor of insecurity.In these cases it could be suspected that the icp-value has been inaccurate during the care of the patient.It has also occurred gauges where the measured values increase considerably, and stays at a high but measurable level and where clinical staff not has connected the situation at hand to a technical error, but interpreted that the patient has an impaction of the brain.In this case the patient has received pharmaceutical treatment and ct-scan before the gauge finally is changed to a new one.Consequences of incidents: additional x-ray, additional pharmaceutical treatment, one additional intracranial surgery.Actions taken: it has happened, even though the staff has not been in contact to the bed/patient, that esd occurs and the codman-equipment (the microsensor in the head + the icp express cable outside the head) are put out of function.As it in some cases been enough to exchange the icp express cable to receive the icp-registration again there is a troubleshooting made as a first step.But there has for several patients also meant an extra surgery / another intracranial surgery when the microsensor is broken.

• Brand Name: 8ROHS MICROSENSOR W/SINGLE LUMEN PLASTIC BOLT (ADULT & PEDIATRIC)
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount dr.; raynham MA 02767 0350
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount dr.; raynham MA 02767 0350
• Manufacturer Contact: james kenney ; 325 paramount dr.; raynham, MA 02767-0350 ; 5088282726
• MDR Report Key: 5507218
• MDR Text Key: 288818069
• Report Number: 1226348-2016-10111
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 62-6632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 82-6632; 82-6635; 92-6636
• Patient Outcome(s): Required Intervention