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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 06/30/2011
Event Type  Injury  
Event Description

It was reported via clinic notes received that the pt has a history of obstructive sleep apnea and uses a cpap. The pt was also noted as having asthma. The relationship of these events to vns is unk. Diagnostics taken on (b)(6) 2011, indicate normal device function. Attempts for additional info have been unsuccessful to date.

 
Event Description

Additional information was received as an implant card containing generator product information.

 
Event Description

Additional information was received from the physician indicating that the patient has a long history of obstructive sleep apnea. It was originally believed to be related to the patient's seizure behavior; however, this began to be questioned on (b)(6) 2002. The relationship of the sleep apnea to vns has not been documented. The cpap use was noted as improving the sleep apnea. No changes to vns settings have been made as intervention to the sleep apnea. The patient was noted as having a sleep study done on (b)(6) 1999 secondary to large adenoids.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
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 Key2338065
Report Number1644487-2011-02711
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number102R
Device LOT Number016158
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/25/2012
Was Device Evaluated By Manufacturer? No
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: 11/10/2011 Patient Sequence Number: 1
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