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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 09/09/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was subsequently disabled and the patient was referred for surgery. The patient¿s physician was suspecting a potential issue with the lead. No known surgical interventions have occurred to date.

 
Event Description

Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient complained of having shocking sensations in her neck along with dysphagia and muscle spasms. The patient had temporarily disabled her device with her magnet and the physician programmed the device off during the office visit. During an office visit on (b)(6) 2014, the patient¿s device was programmed back on and the patient subsequently had a nose bleed and coughing with stimulation. The patient¿s device was tested and showed normal device function at the time. The patient¿s device was again disabled for comfort. No patient trauma or programming changes preceded the onset of the patient¿s issues. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Follow-up report #1 inadvertently did not include that the patient also experienced difficulty speaking during clinic visit on (b)(6) 2014.

 
Manufacturer Narrative

Event description, corrected data: follow-up report #1 inadvertently did not include patient's difficulty speaking during clinic visit on (b)(6) 2014.

 
Event Description

Information was received that the patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were reported to be discarded and could not be returned to manufacturer.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4132917
Report Number1644487-2014-02529
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 09/09/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number304-20
Device LOT Number2639
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2010
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: 10/01/2014 Patient Sequence Number: 1
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