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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/10/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported the patient's neurologist believed there was an infection at the generator site. The patient was then referred to the surgeon for confirmation. The surgeon referred the patient for explant due to the infection. Clinic notes were later received and it was found the patient stated there was a blister, wires were exposed, and still brown drainage. It was also noted the surgeon was going to perform a vocal cord evaluation due to vns placement on the left, and possible place the new vns on the right. The surgeon stated he wants to evaluate the recurrent laryngeal nerve to verify the nerve is stable on both sides. The patient had his generator and lead explanted on (b)(6) 2016. It was noted the generator was completely out of the pocket upon arriving to the hospital. The lead and generator were returned to the manufacturer. Analysis is expected but has not been completed to date.

 
Manufacturer Narrative

Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. This information was inadvertently left off of the initial mfr. Report.

 
Event Description

Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. It was reported the physician wanted to re-implant the generator on the patient's right side and tunnel the lead to the left vagus nerve as to avoid compromising the original pocket on the left side that had been treated with antibiotics. Product analysis for both the lead and the generator were completed and no anomalies were noted.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key5670914
Report Number1644487-2016-01088
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 04/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number103
Device LOT Number203044
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/16/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/20/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2014
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: 05/20/2016 Patient Sequence Number: 1
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