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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Device Problem Insufficient Information (3190)
Patient Problems Headache (1880); Pain (1994); Seizures (2063); Tingling (2171); Dizziness (2194); Dysphasia (2195); Anxiety (2328); Discomfort (2330); Numbness (2415); Palpitations (2467)
Event Date 05/02/2011
Event Type  Injury  
Event Description

On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

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Manufacturer (Section D)
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston, TX 77058
MDR Report Key2103698
MDR Text Key2147716
Report Number1644487-2011-01132
Device Sequence Number1
Product Code LYJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/02/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number102
Device LOT Number2537
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/02/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 05/23/2011 Patient Sequence Number: 1