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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 06/01/2012
Event Type  Injury  
Event Description

The reporter indicated via clinic notes dated (b)(6) 2013 to the manufacturer that the vns patient had been experiencing different seizure types under normal stimulation. The patient experienced a total of three tonic-clonic seizures in (b)(6) 2012, for which there was no clear reason why they occurred. The patient experiences atonic seizures, starting in (b)(6) 2012, weekly. These are drop attacks and the patient falls down with loss of consciousness. The patient had generator replacement surgery performed on (b)(6) 2013 due to reported end of service. The explanted generator will not be returned from the hospital per the hospital's policy. All attempts for additional information have been unsuccessful to date.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3121521
Report Number1644487-2013-01387
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number103
Device LOT Number1979
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2008
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: 05/21/2013 Patient Sequence Number: 1
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