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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 07/28/2010
Event Type  Malfunction  
Event Description

It was initially reported in a patient's clinic notes that on (b)(6) 2010, the patient's settings were 1 ma/25 hz/250 microsec/14 sec/3 min. The doctor noted that the patient's vns current was "increased back to 1. 25 ma. However, when the system was reprogrammed the default settings were restored and the pulse width jumped to 500. [the patient] received one stimulation at this current strength and width and had significant symptoms. He had pain in his neck and pain in his head. He coughed and had difficulty catching his breath during the coughing. The device was immediately interrogated again and the settings were returned to the previous settings and he tolerated that well. The device was again interrogated to assure that it had returned to its typical settings. [he] recovered from the strong stimulus and was again himself within moments. " good faith attempts to gain more information have been unsuccessful to date.

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Manufacturer (Section D)
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
MDR Report Key2061986
Report Number1644487-2011-00705
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/07/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/03/2009
Device MODEL Number103
Device LOT Number200693
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/07/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial