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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 12/01/2014
Event Type  Injury  
Event Description

It was reported that the patient was experiencing severe pain with device stimulation. The device was programmed off and the patient was referred to an ent for evaluation. It was reported that the patient may undergo surgery to prevent a serious injury. No additional relevant information has been received to date. No known surgical intervention has been performed to date.

 
Manufacturer Narrative

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key4413014
Report Number1644487-2015-03604
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 12/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2017
Device MODEL Number304-20
Device LOT Number202602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/15/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2013
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: 01/13/2015 Patient Sequence Number: 1
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