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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 03/16/2011
Event Type  No Answer Provided  
Event Description

Reporter indicated that in addition to the vocal cord paralysis, she has also experienced worsening asthma since the vns was implanted.

 
Event Description

Rptr indicated that since she was implanted with the vns in (b)(6) 2011, she was experiencing vocal cord paralysis when the vns would stimulate. The rptr stated she had a bronchoscopy performed and it was confirmed the left vocal cord had "some sort of paralysis" during vns stimulation. The patient did not wish to have the vns disabled by her treating neurologist. Mfr follow up with the treating neurologist's office revealed the neurologist was aware of the pt's reported vocal cord paralysis, but that the pt had been released from their practice as of (b)(4) 2011 and they had no info. The office did state that the pt was seen on (b)(6) 2011 and the vns was working properly at that time. In addition, the pt refused to have the vns disabled. It is unk which physician the pt may be seeing at present.

 
Event Description

Reporter indicated the patient may be seen by a neurosurgeon for evaluation of the patient¿s neck at the patient¿s request, but no surgery date has been set. The reporter declined to provide additional information.

 
Manufacturer Narrative

The event of the patient's worsening asthma was inadvertently omitted from the initial mdr report.

 
Event Description

Clinic notes from the new treating physician were received indicating surgery to replace the vns generator and possibly the lead may be done in order to relieve the patient's symptoms of voice alteration, dyspnea and painful stimulation. It is suspected the lead placement may be the cause of the patient's adverse events. A surgery date has not been set. Attempts for additional information are in progress.

 
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Brand NameLEAD MODEL 304
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 Key2405348
Report Number1644487-2012-00052
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number304-20
Device LOT Number201623
Was Device Available For Evaluation? No
Date Manufacturer Received05/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2010
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: 01/09/2012 Patient Sequence Number: 1
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