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U.S. Department of Health and Human Services

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

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VP SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Udi: unknown product code, udi unavailable. 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.
 
Event Description
As reported by the patient's father, a vp shunt malfunctioned. "my son is (b)(6) and has a programmable vp shunt. He had a shunt installed shortly after birth. It lasted quite a while i. E, until he was (b)(6). He then had to have a new shunt put in, with this one being a programmable shunt. Last year he had an issue and the shunt had stopped working. The neurosurgeon reprogrammed the setting and he had immediate relief. Recently he has again had a problem. We are working with the doctor to determine what is causing the problem and the next course of action.
 
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Brand NameVP SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6567537
MDR Text Key75180231
Report Number1226348-2017-10322
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 other
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
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 Received04/25/2017
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 Treatment Data
Date Received: 05/15/2017 Patient Sequence Number: 1
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