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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 09/20/2011
Event Type  Malfunction  
Event Description

On (b)(6) 2011, a vns patient reported that she is having more petite mal seizures than usual. However, she still hasn't had any grand mal seizures as she did prior to being implanted with vns. She reported that the physician stated that her vns was fine and is not sending her for battery replacement at this time. The patient believes that her seizures are stress related. Additional information has been requested from the physician concerning the patient's increase in petit mal seizures but no further information has been received to date. The patient's programming history was reviewed and the patient was last programmed to output=2. 5ma/frequency=20hz/pulse width=130usec/on time=7sec/off time=0. 8min/magnet output=2. 5ma/magnet pulse width=130usec/on time=7sec on (b)(6) 2011. The last system diagnostics listed was from (b)(6) 2010, which showed output=ok/lead impedance=ok/dcdc=2/eri=no. A battery life calculation was performed with the programming history available which showed 2. 16 years until eri=yes.

 
Event Description

On (b)(6) 2011, additional information was received when the manufacturer's consultant reported that the physician said that the vns patient is doing fine with vns and there are no issues with the device. The physician believes the increased seizures were due to stress and not the vns. The patient does not need to have the vns replaced at this time.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 101
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2287902
Report Number1644487-2011-02420
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/12/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2003
Device MODEL Number101
Device LOT Number4919
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/14/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/04/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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