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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing increased painful stimulation at the generator site and an increase in seizures since (b)(6) 2014. The patient¿s vns generator was disabled due to pain and the patient was referred for surgery to explant the device. The patient¿s explant surgery was being planned for patient comfort. No known surgical interventions have occurred to date. Follow-up revealed that the patient¿s increase in seizures were worse with vns stimulation. The patient did not have any seizures while the device was disabled. The physician stated that the pain was due to the presence of the device. The patient¿s device was tested and showed normal device function.

 
Event Description

It was inadvertently reported in the initial mdr that no surgical interventions have occurred to date. The patient underwent explant of the vns device but the explant facility chose not to return the explanted generator. Therefore, product analysis of the explanted generator could not be performed.

 
Manufacturer Narrative

Event description, corrected date: it was inadvertently reported in the initial mdr that no surgical interventions have occurred to date. If explanted, give date (mo/day/yr), corrected data: 11/17/2014. The explant date was inadvertently left off from the initial mdr report.

 
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Brand NamePULSE GEN MODEL 103
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 Key4277380
Report Number1644487-2014-03131
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 10/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number103
Device LOT Number3119
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/16/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2011
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: 11/25/2014 Patient Sequence Number: 1
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