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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 10/19/2011
Event Type  Injury  
Event Description

Reporter indicated a vns patient had a drooping left eyelid. The patient was newly implanted with the vns two days earlier, and the drooping eyelid was not present prior to the surgery per the reporter. Follow up with the vns implanting surgeon revealed the drooping eyelid (horner syndrome) was diagnosed prior to the vns being implanted. Attempts for further information are in progress.

 
Event Description

Additional follow-up with the treating surgeon revealed the patient's drooping eyelid/horner syndrome was not related to the vns device.

 
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Brand NamePULSE GEN MODEL UNK
Type of DevicePULSE GEN MODEL UNK
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 Key2340907
Report Number1644487-2011-02775
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 10/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/17/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/17/2011 Patient Sequence Number: 1
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