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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 12/01/2012
Event Type  Injury  
Manufacturer Narrative

Analysis of programming history.

 
Event Description

Clinic notes dated (b)(4) 2013 indicated that this patient was having 2-3 seizures per month (but up to 4 in a month) but could go 3-4 months without a seizure. Seizures occurred when the patient was stressed or upset. , the patient had seizures a few months ago due to her daughter¿s wedding. The notes indicated that the magnet did not appear to be helpful for 8 months. It was normally useful in aborting seizures. The device was last interrogated by this physician in (b)(6) 2010 when the patient was last seen. The patient had a previous procedure for a pulmonary embolism. The patient had events of deep vein thrombosis. The patient magnet and vns were not functioning 8 months. The recent worsening was likely due in part o the ns no longer functioning with the patient feels began 8 months prior. Notes dated (b)(6) 2010 indicated that the patient denied any suicidal thoughts but still had some bouts of depression, and settings were provided. Surgery is likely but has not taken place. A battery life calculation shows 0. 13 years remaining.

 
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Brand NamePULSE GEN MODEL 102
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 Key3373843
Report Number1644487-2013-02964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/29/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number102
Device LOT Number200908
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/29/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/02/2008
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: 09/27/2013 Patient Sequence Number: 1
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