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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 08/20/2014
Event Type  Injury  
Event Description

It was reported that during planned implant surgery the surgeon was unable to locate the patient's vagus nerve, so the surgery was cancelled. The patient was referred to an ent for evaluation and mri, so the surgeon could visual the patient's anatomy at the time of implant. It was later reported that the patient has a congenital absence of the left vagus nerve (no large nerve in the sheath). The patient will undergo imaging to check vocal cord function before considering right sided implant.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key4198932
Report Number1644487-2014-02817
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/26/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2014
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 Received09/26/2014
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: 10/24/2014 Patient Sequence Number: 1
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