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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Event Date 12/08/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed high impedance. The patient previously underwent generator replacement surgery on 6-8 weeks prior to the high impedance observation. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient underwent lead revision surgery on (b)(6) 2015 for replacement of the lead. The explanted lead has not been returned to the manufacturer to date.

 
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Brand NameLEAD MODEL UNKNOWN
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 Key4390986
Report Number1644487-2015-03532
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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