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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 07/29/2012
Event Type  Injury  
Event Description

Clinic notes dated (b)(4) 2012 indicated that this vns patient was diagnosed with a pulmonary embolism and pneumonia on (b)(6) 2012. The patient's device was interrogated on (b)(6) 2012 and found to be operating nominally and was not at end of service. (the patient had a seizure on (b)(6) 2012 that resulted in her going to hd. ) settings from (b)(6) 2012 were provided. A review of systems was positive for chest pain and irregular heartbeat/palpitations; however, the status of the patient's cardiovascular system indicated regular rate and rhythm and no murmurs, gallops, or rubs. Notes dated (b)(4) 2012 were provided. Notes on both dates indicated that the status of the patient's cardiovascular system indicated regular rate and rhythm and no murmurs, gallops, or rubs. Attempts for additional information have been unsuccessful.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2995749
Report Number1644487-2013-00665
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number102
Device LOT Number2652
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/08/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/22/2010
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: 03/08/2013 Patient Sequence Number: 1
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