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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/07/2015
Event Type  Injury  
Event Description

It was reported that the vns patient underwent surgery to explant her device due to lack of efficacy. Follow-up indicated that the reason for surgery was throat pain and dyspnea. No further information relevant to the event has been received to date.

 
Event Description

It was reported from the physician's office that the patient hasn't actually been seen since 2013. The nurse indicated that the reason for replacement is not actually known since the patient has not been seen and the mention of throat pain and shortness of breath was a serious issue. She had no more information to provide about the adverse events mention since these occurred a couple of years ago she is no longer their patient. She did not know the patient's current physician. This was all the information provided.

 
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Brand NamePULSE GEN MODEL 102
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 Key4515632
Report Number1644487-2015-03826
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number102
Device LOT Number2652
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/27/2010
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: 02/13/2015 Patient Sequence Number: 1
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