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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 08/01/2010
Event Type  Injury  
Event Description

It was initially reported by the treating nurse practitioner that the pt was recently diagnosed with sleep apnea. The nurse believed that they were going to attempt to disable the device in the evenings during sleep to see if that would help resolve the issue as he was not having seizures at night, so the therapy was not needed at that time. The pt later reported that he believed the device was going to be disabled. He said that he was having difficulties breathing, had sinus issues, couldn't breathe through the nose, tightness in his chest and was not getting any sleep. He was said to have had a sleep study which did not provide any further info on the issues. He reported that when the magnet was taped to his chest, the issues resolved. The pt also reported the physician did not believe there was anything wrong with his heart. The pt claimed that since his lead and generator repositioning in 2008 (at the pt's request), he has lost seizure control since the seizures have returned to pre-vns baseline levels and the magnet activations have no longer become affective. The pt is requesting removal of the device. Programming history reviewed in manufacturer's programming history database indicating that the last known diagnostics performed were within normal limits. Good faith attempts to obtain additional info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1889162
Report Number1644487-2010-02436
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2007
Device MODEL Number102
Device LOT Number014628
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/30/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2005
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: 10/29/2010 Patient Sequence Number: 1
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