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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 04/17/2013
Event Type  Injury  
Event Description

It was reported that the vns patient experienced vomiting, melena, abdominal pain, and other various gi issues since (b)(6) 2013. The physician stated that the patient¿s symptoms were more consistent with colitis per colonoscopy. The physician believed that the events were more likely gi related but was unable to rule out vns as a contributing factor. The patient¿s device settings were subsequently decreased. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received that the vns patient was seen and it was determined that their events were not related to their vns, but rather to colitis.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 105
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 Key4425509
Report Number1644487-2015-03626
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 12/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number105
Device LOT Number202547
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2013
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: 01/16/2015 Patient Sequence Number: 1
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