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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/13/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(4) 2014 noted that the patient has had increasing episodes where she feels like she is going limp, her head goes ack and her eyes roll back. It was noted that the patient is sleepy the remainder of the day and that this has been occurring for approximately 4-5 months. The device was interrogated and ifi was no. The device output current was increased from 1. 75ma to 2ma. The patient was referred for surgery. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

 
Event Description

Clinic notes were received for reimbursement purposes on (b)(6) 2015. Notes dated (b)(6) 2015 indicate that the patient's generator is 10 years old and that it is nearing end of life. Patient was also reported to be having seizures and was referred for generator replacement. Notes dated (b)(6) 2015 from the generator replacement surgery indicates that the patient had increased seizures.

 
Event Description

Patient underwent prophylactic generator replacement on (b)(6) 2015. The explanted generator was reported to be discarded.

 
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Brand NamePULSE GEN MODEL 102
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 Key4329443
Report Number1644487-2014-03309
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015424
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2006
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: 12/15/2014 Patient Sequence Number: 1
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