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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 04/01/2013
Event Type  Injury  
Event Description

Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2014. The notes listed epigastric abdominal pain as one of the patient¿s current problems.

 
Event Description

On (b)(6) 2013, a patient¿s mother reported that her son developed gastroparesis in (b)(6) 2013. The mother stated that the physician had said they have no information on what it could have been caused by. The patient¿s device was last interrogated on (b)(6) 2013, and to the mother¿s knowledge, everything was ok. There were no noted events that preceded the gastroparesis. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 104
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 Key3452684
Report Number1644487-2013-03400
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 10/07/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number104
Device LOT Number20213
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/27/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2012
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: 11/06/2013 Patient Sequence Number: 1
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