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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 12/01/2010
Event Type  Injury  
Event Description

Additional information was received from the physician indicating the patient's different seizure type was first noted on (b)(6) 2011. When asked, the physician attributed the different type of seizure to "different type of seizure. " the toleration issues were clarified to be coughing. No trauma or manipulation was believed to have occurred. The physician indicated she was able to titrate the patient up slowly and he was able to tolerate the changes in settings well. No programming or medication changes were believed to have caused or contributed the tolerability or seizures. Diagnostic results were requested but not provided.

 
Event Description

It was reported via clinic notes received dated (b)(6) 2012, that the vns patient noted at a previous office visit on (b)(6) 2011, that he had experienced a "different type of seizure" involving collapsing without warning. One such collapse was noted as occurring in (b)(6) 2010, that required the patient to go to the emergency room and resulted in a significant hematoma in his neck. The patient had another one of these episodes in (b)(6) 2011. The notes from (b)(6) 2011, indicated that the patient had not noticed any improvement from vns therapy however another note dated (b)(6) 2012, indicated "now doing well with higher stimulations" regarding the vns. The note dated (b)(6) 2012, indicated the patient "could not tolerate higher stimulus" however the patient's seizure frequency was noted as 3 seizures per month at that time versus 4-5 seizures per month indicated on the note regarding the visit on (b)(6) 2011. The patient was noted as being compliant with medications. Last known diagnostics were taken on (b)(6) 2008. Attempts for additional information have been unsuccessful 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 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 Key2720243
Report Number1644487-2012-02166
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2006
Device MODEL Number102
Device LOT Number010275
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/31/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/23/2004
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: 08/30/2012 Patient Sequence Number: 1
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