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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
Device Problems Generator; High impedance
Event Date 07/01/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device had returned high impedance upon diagnostics in (b)(6) 2015. The patient¿s generator was implanted in the axilla. The patient had been implanted in (b)(6) 2014 with a generator model 102. It was reported that the vns therapy had yielded benefit for the patient. In (b)(6) 2015 system and normal mode diagnostics were run and they returned impedance within normal ranges, with dcdc2 and dcdc3 respectively. Diagnostics performed early in (b)(6) 2015 returned high impedance. The patient underwent a generator replacement in mid (b)(6) 2015 with a generator model 103. No x-rays were taken. Diagnostics were run in (b)(6) 2015 on the generator model 103 and they returned high impedance with 9000 ohms. The patient¿s settings at the time were programmed at 2ma, 30sec on-time, 5 min off-time. Diagnostics were run on (b)(6) 2015 which returned high impedance 5000 ohms. The patient¿s generator was not switched off upon parents request as it is believed that the patient is still having benefit from vns. A lead surgical revision is expected but it has not been confirmed to date.

 
Event Description

Further information received indicates that the device was disabled.

 
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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 Key5133935
Report Number1644487-2015-06043
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 09/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/07/2015
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 Received11/23/2015
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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