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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 06/21/2006
Event Type  Malfunction  
Event Description

It was reported by the patient that he had been having worsening depression for about a year to a year and a half. The patient also stated that he had been having suicidal thoughts since being implanted with vns however it is unknown if these had worsened since implant or pre-existing. Per the patient, the physician had previously informed him that his vns "wasn't charged" or was "malfunctioning" however he did not have any further information. The patient stated that he still feels stimulation and that it has not changed at all so he did not believe there was an issue with the battery. Attempts for further information have been unsuccessful to date.

 
Event Description

Additional information was received indicating the patient wants to have his vns explanted. The patient noted that the vns did not help his depression. The patient confirmed the physician indicated to him that the "vns was not working anyway. " the patient intends to pursue explant of the vns however it is unknown if it will occur at this time.

 
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Brand NamePULSE GEN MODEL 102
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2355590
Report Number1644487-2011-02915
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014277
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/07/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/14/2005
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: 12/01/2011 Patient Sequence Number: 1
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