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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 03/15/2013
Event Type  Injury  
Event Description

It was reported that a vns patient since being implanted (b)(6) 2013 presented with drowsiness, with nausea, vomiting, anorexia, aspiration when feeding from the implant. No rhythmicity depending on the frequency of stimulation. The patient therapy has been titrated per their study protocol. The patient had persistence of their symptoms the parents contacted the surgeon, who offered to temporarily stop their therapy to see if there would be improvement and check relationship to their device. Symptoms partially regressed between (b)(6). They disabled their device on (b)(6), and started again with modified settings (b)(6) the 2013. In the meantime, no change in symptoms. Their following physician does not think that the symptoms are related to the stimulation, provided that the patient has since developed a cold sore and fever. Only food-initial aspirations are potentially linked, in their opinion. No change in medication was reported and no medicinal treatments.

 
Manufacturer Narrative

 
Event Description

It was reported that the events resolved on (b)(6) 2013.

 
Manufacturer Narrative

Date of event: new information identified when the events started.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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 Key3132031
Report Number1644487-2013-01599
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2014
Device MODEL Number102
Device LOT Number3467
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/05/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/13/2012
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: 05/29/2013 Patient Sequence Number: 1
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