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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 11/03/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing painful stimulation in her neck. The patient¿s device was tested and system diagnostic results revealed high impedance. The patient¿s device was not subsequently disabled. X-rays were taken and reported to show a gross lead fracture next to a tie-down. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted device were returned to the manufacturer for analysis. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications. Analysis of the returned lead is currently underway.

 
Event Description

Analysis of the returned lead portions were completed. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4295204
Report Number1644487-2014-03202
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2002
Device MODEL Number300-20
Device LOT Number845
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/22/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/19/2000
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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