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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL UNK GENERATOR

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CYBERONICS INC PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Type  Injury  
Event Description

An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events. Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant. One patient had wound dehiscence one week following surgery that was surgically treated. One patient had to undergo surgery to reposition the device due to protrusion. One patient underwent surgery due to a lead issue. Five patients were noted to have experienced significant weight loss due to decrease in appetite. Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help. Two patients were non-responders but experienced significant weight loss that required either device removal or disablement. This manufacturer report involves the wound dehiscence that was surgically treated.

 
Manufacturer Narrative

Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis. Aburahma, samah k. Et al. Seizure - european journal of epilepsy.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4377796
Report Number1644487-2015-03504
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/05/2014
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 TREATMENT DATA
Date Received: 01/02/2015 Patient Sequence Number: 1
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