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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 01/10/2013
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The identity of the patient's current physician was confirmed. However no additional relevant information has been received to date in regards to the patient's congestive heart failure.

 
Event Description

The patient reported that she developed congestive heart failure while on vns therapy and that her physician believes that the vns is causing her heart issues. The patient had made a similar report in 2013 however her treating physician at the time denied that vns was causing the congestive heart failure. The previous physician has not seen the patient recently. The identity of the patient's current physician is unknown. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key6182955
Report Number1644487-2016-02900
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation Patient
Type of Report Followup
Report Date 01/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2007
Device MODEL Number102
Device LOT Number014097
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2006
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: 12/16/2016 Patient Sequence Number: 1
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