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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 09/01/2014
Event Type  Injury  
Event Description

Additional information was received indicating that the patient did not have anorexia prior to vns. The physician stated that the patient¿s anorexia was related to vns. The explant surgery was elective and not to preclude a serious injury. It was noted that the patient¿s device settings were not able to be increased to therapeutic levels due to the patient¿s tolerability issues with anorexia.

 
Event Description

It was reported that the vns patient began experiencing weight loss and anorexia in (b)(6) 2014 that may be related to vns. The healthcare profession indicated that the patient¿s medications may be related to the event and that the patient had a history of weight loss prior to vns. The patient¿s mother determined to proceed with device explant. It was noted that the patient had not received efficacy from his device. No known surgical interventions have occurred 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 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 Key4614392
Report Number1644487-2015-04175
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 02/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number102
Device LOT Number202460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2013
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: 03/18/2015 Patient Sequence Number: 1
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