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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VALVE PROGRAMMER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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VALVE PROGRAMMER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 04/06/2017
Event Type  Injury  
Manufacturer Narrative
Udi: unknown part number, udi unavailable. Upon completion of the investigation, a follow up report will be filed.
 
Event Description
As reported by the rep, a physician was unable to get a valve programmer to function while trying to reprogram a hakim valve. It was reported that the patient had to be taken to fluoro to be identify the valve. Another programmed was then used to program the valve.
 
Manufacturer Narrative
Complaint sample was not returned to codman and no product code or lot number information was provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. Complaint will be closed at this time as 'no complaint sample returned to codman for evaluation'. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
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Brand NameVALVE PROGRAMMER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6545770
MDR Text Key74473680
Report Number1226348-2017-10304
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/04/2017 Patient Sequence Number: 1
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