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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

 
Event Description

A patient's father reported that his son experienced an infection and redness around his vns after a recent full revision surgery. The device history records were reviewed for the lead and generator and revealed that the devices were sterilized according to specifications prior to release. No additional relevant information has been received to date.

 
Event Description

The patient's neurologist reported that the implanting surgeon explanted the patient's vns due to the infection. Clinic notes were received and indicated that the patient's primary care physician observed a skin problem and rash. The patient was admitted to the emergency department for worsening swelling and spreading erythema around the vns generator. The patient was noted to be itching at the sites. Antibiotics were administered. The patient underwent lead and generator explant due to the supposed infection. The patient had attended a surgical consult two days prior to surgery and exhibited signs of progressive erythema, when it was recommended that the vns be removed. Operative notes indicated that the patient had a 2-3 cc seroma around the generator without obvious sign of infection. The generator and leads were removed and sent for culture, as well as a culturette of the generator pocket itself. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7061966
Report Number1644487-2017-04864
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 01/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/10/2018
Device MODEL Number106
Device LOT Number5050
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/15/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/18/2016
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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