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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 03/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient developed apathy and anorexia after his device was first programmed on. The physician is looking at multiple possible etiologies. The patient has pituitary dysfunction due to six brain surgeries for a pinealoma. The patient¿s device was programmed off during an office visit on (b)(6) 2014. Further follow-up revealed that the patient was last seen on (b)(6) 2014. At that time, it was noted that the patient had gained weight and had improved mental status since the device was programmed off. The patient was previously overweight and had been very talkative. Clinic notes from the patient¿s office visit stated that the patient¿s issues were likely not related to vns as the patient¿s device settings were very low. It was also noted that the patient had recently moved, and this may have had an effect on the reported events. The patient¿s device was to remain programmed off until the patient¿s next office visit.

 
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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 Key3792218
Report Number1644487-2014-01180
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2015
Device MODEL Number105
Device LOT Number3811
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2013
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: 05/06/2014 Patient Sequence Number: 1
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