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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 02/25/2011
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Report received that vns caused a patient's seizure type to change from grand mal to partial complex and atonic. No further relevant information has been received to date.

 
Manufacturer Narrative

Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device since the physician confirmed the event invalid.

 
Event Description

Further information was received that identified the patient. It was found that this patient was originally implanted 7 years ago and had a prophylactic battery replacement within that time. Since the original report was that the vns had caused a change in seizure type, it was suspected that both generators potentially contributed to the change in seizure pattern. After the patient was identified, her physician was contacted for more information regarding the event. Follow-up from the physician indicated that the patient was likely confused when she made the allegation. The physician indicated that the patient had always had complex partial seizures and specifically had partial seizures with secondary generalization. The physician confirmed that the patient's seizure type had not changed since vns therapy and that the patient's statement about a change in seizure type was incorrect. The physician confirmed that the first replacement was a prophylactic battery change and not due to any concern of a device issue or serious injury. The newer generator was reportedly recently checked and diagnostics were within normal limits. The only available diagnostic information from the first generator was from the date of implant. But, the results were within normal limits. No further relevant information has been received 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
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 Key7192007
Report Number1644487-2018-00087
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/01/2012
Device MODEL Number102
Device LOT Number201513
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/16/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/09/2010
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: 01/15/2018 Patient Sequence Number: 1
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