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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 02/04/2013
Event Type  Injury  
Event Description

Reporter indicated a patient was seen urgently on (b)(6) 2013 after having 3 strong seizures in which the patient's head was turned to the right. The word "pledget" was used to describe strain in the vns lead wire with the neck muscle. The patient's device is currently disabled for 10-14 days and then the patient was to have the device re-tested. X-rays did not visualize the top of the lead wire but the area observed did not show any overt breaks per the reporter. All attempts for additional information have been unsuccessful to date.

 
Event Description

Reporter indicated the patient's lead-pulling sensation was possibly due to the patient's strong seizures which may have caused inflammation along the lead wire. There was no specific patient trauma experienced other than the previously reported strong seizures which may have been the cause. The vns was disabled for two weeks, and then turned back on (b)(6) 2013. There have been no issues reported since that time. Current diagnostics are within normal limits. The "pledget" noted is felt to be the tie-down securing the lead in the neck.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2987998
Report Number1644487-2013-00583
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device MODEL Number304-20
Device LOT Number3204
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2011
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: 03/04/2013 Patient Sequence Number: 1
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