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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/01/2013
Event Type  Injury  
Event Description

It was reported by the patient that the generator had migrated towards her arm pit leading to the wrapping of the lead around her thyroid thus causing damage to her left vocal cord for which surgery would have to take place, specifically, removal of the left vocal cord. Attempts for further information from the physician have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

It was reported from the physician that the patient was seen on (b)(6) 2015 and the patient states she believed the device had migrated but she saw the surgeon and no surgery is needed as of (b)(6) 2015. No surgery or interventions that are known have occurred to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4680987
Report Number1644487-2015-04432
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 03/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number103
Device LOT Number3233
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2012
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: 04/10/2015 Patient Sequence Number: 1
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