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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 07/06/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient had a significant infection at her vns site shortly after implant. The infection was treated with antibiotics and got better, but the patient presented later with drainage from her vns site and signs of infection. Cultures were performed, and the patient was referred to the surgeon. The device history records of the generator and lead were reviewed, and both devices were sterilized prior to release. No further relevant information has been received to date.

 
Manufacturer Narrative

Device evaluated by mfr? no. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

 
Event Description

Additional information was received that the patient underwent generator replacement surgery. The generator was replaced because patient's skin at generator site eroded and the generator was exposed. The surgeon removed it from the pocket on the left side and implanted the new generator on the right side. The explanted generator was discarded. According to the neurologist, the infection was ongoing. It would clear up for sometime and then come back. Based on that he made decision to replace the generator and move pocket to right side of her chest.

 
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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 Key6193059
Report Number1644487-2016-02926
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/13/2018
Device MODEL Number106
Device LOT Number203782
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/05/2016
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: 12/21/2016 Patient Sequence Number: 1
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