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Adverse Event Report

CODMAN & SHURTLEFF, INC./MEDOS S.A. NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL MONITORING   back to search results
Catalog Number 82-6631
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

International affiliate reports microsensor failed to provide stable readings. Sensor initially gave negative readings with several dramatic variations in intercranial pressure readings. Sensor found by surgeon not to be reliable. Affiliate reports no adverse consequences; however, request was made to affiliate on 5/24/01 for add'l info/clarification concerning this event. To date, that info has not been received.

 
Manufacturer Narrative

See h10.

 
Manufacturer Narrative

The microsensor has been returned for eval. Results will be forwarded to the fda upon completion of the eval.

 
Event Description

Additional info provided by affiliate. The microsensor remained in pt's brain for approximately 3 days with some variation in pressure which indicated sensor might be faulty. Surgeon was not satisfied that the sensor was stable but determined from a combination of some sensor readings and a scan that the pt had a low pressure headache. The pt returned to the hospital and a programmable valve was implanted.

 
Manufacturer Narrative

Exam of the returned device found multiple bends, twists, and kinks in the catheter. Also, the catheter had been stretched, which caused the wires to break. The complaint cannot be confirmed as the damage due to improper user handling. At this time, the complaint is considered to be closed.

 
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Brand NameNEUROMONITOR BASIC KIT
Type of DeviceDEVICE, INTRACRANIAL MONITORING
Baseline Brand NameNEUROMONITOR BASIC KIT
Baseline Generic NameDEVICE, INTRACRANIAL PRESSURE MONITORING
Baseline Catalogue Number82-6631
Baseline Device FamilyNEUROMONITOR BASIC KIT
Baseline Device 510(K) NumberK914479
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed03/07/1994
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC./MEDOS S.A.
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SWITZERLAND CH-2400
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC./MEDOS S.A.
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SWITZERLAND CH-2400
Manufacturer Contact
matthew king
325 paramount drive
raynham , MA 02767
(508) 828 -3106
Device Event Key324367
MDR Report Key335028
Event Key315314
Report Number1226348-2001-00101
Device Sequence Number1
Product CodeGWM
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 04/30/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number82-6631
Device LOT Number120910
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2001
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/30/2001
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on February 28, 2009

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