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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 03/01/2016
Event Type  Injury  
Event Description

On (b)(6) 2016 it was reported that the patient has been having "multiple breakthrough seizures" and the physician is considering implanting him with a model 106 generator as he thinks it may help with the patient's seizures, though it was noted that this would be considered a prophylactic replacement.

 
Event Description

On (b)(6) 2016 it was reported that the patient was scheduled for prophylactic generator replacement on (b)(6) 2016. The clinical reason is that his seizures have increased in number and severity with the current generator. The surgeon has noted heart rate variability in this patient and suggested this new generator model as the "next step". The patient underwent the generator replacement on (b)(6) 2016. The lead impedance for the new implant was ok, 1618ohms. The explanted generator cannot be returned for product analysis per the hospital.

 
Event Description

The surgeon stated that the increase in seizures and increase in severity of the seizures were not related to vns. They were believed to be due to the patient¿s medicine, drug regimen, and disease progression.

 
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Brand NamePULSE GEN MODEL 103
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 Key5570936
Report Number1644487-2016-00780
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL Number103
Device LOT Number202602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/23/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2013
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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