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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem High impedance
Event Date 08/10/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient had high impedance detected on his vns system per interrogation from the neurologist's programming system. Device manufacturing records were reviewed and confirmed that the lead passed all functional tests prior to distribution. It appears the vns device has been disabled. No known surgical interventions have occurred to date.

 
Event Description

Additional information was received that the patient underwent vns generator and lead implant surgery on (b)(6) 2015 due to prophylactic generator replacement and high lead impedance. Pre-op interrogation indicated that the device outputs were programmed off. Pre-op system diagnostic on the patient' device indicated impedance > 10,000 ohms. It was decided to implant this patient's new system on the right side, without removal of the original left side implants. Impedance results were within normal limits on the new device after implant. No additional relevant information ahs been received to date,.

 
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Brand NameLEAD MODEL 304
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 Key5050090
Report Number1644487-2015-05680
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 08/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2017
Device MODEL Number304-20
Device LOT Number3670
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2013
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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