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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 01/07/2013
Event Type  Malfunction  
Event Description

Reporter indicated a patient was to have a prophylactic vns generator replacement surgery, but during a pre-operative vns diagnostics test high lead impedance was noted. The surgeon opted to move forward with the vns generator replacement since he thought it could resolve the issue, but it did not and high lead impedance was still noted after the resident lead was inserted into the new generator. As the high lead impedance did not resolve after reinserting the lead into the new generator, a lead pin issue has been ruled out, and a lead fracture is more likely the cause of the high lead impedance. The new generator was then turned on to previous settings by the surgeon, despite the manufacturer's recommendation to disable the vns generator when high impedance is noted. The explanted vns generator was returned back to the manufacturer on (b)(4) 2013 and is pending analysis. Attempts for additional information are in progress.

 
Event Description

On (b)(4) 2013 the explanted lead and the other explanted vns generator were returned to the manufacturer for product analysis. An implant card was received indicating that the lead was replaced on (b)(6) 2013 due to lead discontinuity.

 
Event Description

It was reported that the patient had the vns generator m102r and lead 300-20 replaced on (b)(6) 2013. Additional information revealed that the patient experienced no trauma and there were no manipulation to the vns lead suspected. The generator was turned off after the surgery and the new implanted generator was turned back on (b)(6) 2013. The m101 generator was returned to the manufacturer. Product return for the explanted product is in progress. Analysis of the vns generator m101 in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury. Corrected data: follow-up report #3 inadvertently listed wrong results and conclusion codes additional manufacturer narrative, corrected data: follow-up report #3 inadvertently stated that analysis did not reveal any anomalies.

 
Event Description

Product analysis on the vns lead and generator was performed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead portion confirmed a discontinuity of the negative coil. Pitting and residual material were also observed on the coil surface of the vns lead.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2942427
Report Number1644487-2013-00278
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/07/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/04/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2002
Device MODEL Number300-20
Device LOT Number443
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/03/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2000
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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