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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
Event Date 03/15/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported on (b)(6) 2016 that the patient's wound has opened up. The vns was recently implanted on (b)(6) 2016. The wound opening was first noticed on (b)(6) 2016. It is believed that the child did a bear crawl when he was playing which may have caused the wound to open. The patient went to the er on (b)(6) 2016 because the site would not close. The physician closed up the site and it was stated that the site was infected and the patient was provided with some medication to remove the infection. The device was not explanted. The physician does not think that the device has the infection on it so he chose not to explant. They plan to monitor the patient.

 
Event Description

The design history record for the lead was reviewed and the device was hp sterilized prior to distribution into the field.

 
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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 Key5563449
Report Number1644487-2016-00744
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Followup
Report Date 03/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/02/2017
Device MODEL Number106
Device LOT Number203634
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2015
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: 04/08/2016 Patient Sequence Number: 1
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