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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 12/01/2011
Event Type  Injury  
Event Description

It was reported that the patient had her generator moved to her right chest from her left chest due to pain at the generator implant site. Per physician, there is no reason to explain the pain and patient was benefiting from vns therapy, so it was decided to move the device. Diagnostics were run during surgery and everything was fine.

 
Event Description

Information from the treating surgeon indicated the intervention was not taken to preclude a serious injury.

 
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Brand NamePULSE GEN MODEL 102
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 Key2406192
Report Number1644487-2012-00038
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2013
Device MODEL Number102
Device LOT Number201844
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/29/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2011
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: 01/06/2012 Patient Sequence Number: 1
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