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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 LEAD

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CYBERONICS, INC. PULSE GEN MODEL 103 LEAD Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2018
Event Type  Injury  
Event Description

It was reported by the company representative that a surgeon was having difficulty placing the lead on the nerve. The surgeon wanted to use a clip on the electrode to secure it to surrounding soft tissue. The surgeon had claimed that the nerve looked ¿ragged¿ and was the reason the electrode was having difficulty staying in position. Additional relevant information has not been received to-date.

 
Event Description

Follow-up from the surgeon provided that the nerve was scarred from the previous vns lead. The scarring around the nerve was associated with the presence of the device and was expected. The clips were used to secure the lead coils around the thickened, scarred nerve. The physician stated the longer lead may have been helpful, but was not available that day. The clips were used to prevent the coils from slipping off the nerve.

 
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Brand NamePULSE GEN MODEL 103
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 Key7403413
Report Number1644487-2018-00525
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number303-20
Device LOT Number204079
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/12/2018
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

Patient TREATMENT DATA
Date Received: 04/06/2018 Patient Sequence Number: 1
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