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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 03/01/2015
Event Type  Injury  
Event Description

It was reported that the patient has experienced a possible increase in myoclonic seizures. The patient's father indicated that the patient is bedridden and they plan to follow-up with the treating neurologist. It is unknown whether or not the increase is above the patient's pre-vns baseline frequency. No additional relevant information has been received to date.

 
Event Description

Follow up indicated that it was not an increase in myoclonic seizures that had occurred, it was an increase in generalized seizures, which are unusual for the patient. The patient's father does not know whether the increase in seizures is above the patient's pre-vns baseline frequency. No additional relevant information has been received to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Corrected data: new information received changes the event from a product problem to an adverse event. This was inadvertently left off of supplemental mfr. Report #01. Corrected data: new information received changes the event from a product problem to an adverse event. This was inadvertently left off of supplemental mfr. Report #01.

 
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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 Key4707252
Report Number1644487-2015-04501
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 03/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2015
Device MODEL Number103
Device LOT Number202627
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2013
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: 04/20/2015 Patient Sequence Number: 1
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