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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 11/20/2014
Event Type  Malfunction  
Event Description

It was reported that the patient's generator was unable to be interrogated. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

On (b)(6) 2016, it was confirmed that the patient's device was able to be interrogated. Patient was seen at the neurologist's office due to recent increase in seizures to evaluate her for continuation of her vns therapy or replacement since her device disablement on (b)(6) 2008 due to seizure freedom. A diagnostic test was performed and patient was able to feel vns stimulation. During the stimulation period of the diagnostic test, patient experienced pain with stimulation in neck area pulled away before the test was completed. Additional information was received that the patient's diagnostic test results were not available as they could not be completed.

 
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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 Key4330779
Report Number1644487-2014-03326
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2005
Device MODEL Number102
Device LOT Number008950
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/12/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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