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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 04/01/2013
Event Type  Injury  
Event Description

It was initially reported that the patient was experiencing painful stimulation. The patient has requested to be explanted due to the painful stimulation and possible lead protrusion in the neck. Information of the surgeon's office was that there did not seem to be anything wrong with the patient's vns and indicated that the patient may not be proceeding with surgery but this was not able to be confirmed. Good faith attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received that the patient is going to have her generator and lead explanted. Surgery if likely but has not occurred to date.

 
Event Description

On (b)(4) 2013 clinic notes were received dated (b)(6) 2013. The clinic notes mention that the patient has a ¿lump in her neck that another doctor had said that the wire is wrapped around¿. The patient stated that her pump has not worked since (b)(6) 2013; that it has been ¿two years since the wire broke¿. The clinic notes mention that the patient has visual hallucinations. The patient was referred for x-rays to check her lead. A copy of the ct of the neck soft tissue was received dated (b)(6) 2012 which indicates that ¿at the site where there was previously felt to be some skin thickening close to the site of the neurostimulator leads, there is still some skin thickening but no increase in the size of the vague density. The apparent sebaceous cyst seen more anteriorly is unchanged¿. It was stated that the patient had complained of a left neck lump and dysphagia. It was stated that this palpable lump is just inferior to the parotid gland but there is no identifiable mass at this site. Slightly anterior to this, there is a small skin lesion which was noted to might be a small sebaceous cyst. The ct scan sated that there is no mass in the region of the palpable lump. The patient underwent a generator replacement on (b)(6) 2013. The explanted generator has not been received for product analysis to date.

 
Event Description

It was reported that the explanting facility discarded the explanted generator and it will not be returned for analysis.

 
Manufacturer Narrative

 
Manufacturer Narrative

Additional information was received which changes the product the report is reported on.

 
Event Description

It was reported that on (b)(6) 2013 the patient had a tumor removed from her neck.

 
Event Description

Additional information was received that the patient had seen the surgeon without a referral from her treating physician. The surgery was cancels and is not currently planned.

 
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Brand NameBIPOL LEAD MODEL 300
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 Key3116210
Report Number1644487-2013-01383
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/16/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2001
Device MODEL Number300-20
Device LOT Number19476C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/1999
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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