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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 06/28/2011
Event Type  Injury  
Event Description

It was initially reported the patient was experiencing blackout spells that were speculated to be syncope related to hypotension; however, it was not confirmed that the blackouts were unrelated to seizures. Good faith attempts have been unsuccessful to date.

 
Event Description

Additional information was received regarding the patient. The syncope that was reported was unrelated to vns.

 
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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 Key2301698
Report Number1644487-2011-02451
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2006
Device MODEL Number102
Device LOT Number001406
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/17/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2004
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: 10/14/2011 Patient Sequence Number: 1
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