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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
Device Problems Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected
Event Date 06/25/2015
Event Type  Malfunction  
Event Description

It was reported that the patient¿s device was turned off for mri on (b)(6) 2015, and turned back on on (b)(6) 2015. At this time the pulse width was increased from 250 to 500. Around 5:30 am on(b)(6) 2015, the patient could not speak or stick out her tongue, and appeared to be in much pain. Device was turned off again and it helped for a while but the issues did not resolve. System diagnostics show result of high impedance. It was also mentioned that the patient recently underwent craniotomy 3 days prior to (b)(6) 2015.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received that the high impedance was first observed on (b)(6) 2015 and was not observed prior to that. Patient was referred for lead revision and prophylactic generator replacement but no surgical interventions have occurred to date.

 
Event Description

Additional information was received that the patient underwent surgery on (b)(6) 2015. It was reported that the patient's implanted generator and lead were not removed as the surgeon did not want to create a new scar. Instead, the surgeon implanted a new vns generator and lead on the right side of the patient. The lead was implanted on the right vagal nerve. The patient and family agreed with the surgeon and therefore the old devices were not touched. The surgeon was informed of the cardiac risks of implanting vns system on the right side. The neurologist was also made aware of the two systems implanted in patient and that the system on the left will show high impedance as this was not corrected. Neither the patient nor the surgeon at this time feels that it is necessary to remove the suspect device.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4907360
Report Number1644487-2015-05166
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2004
Device MODEL Number300-20
Device LOT Number5131
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2002
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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