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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 09/29/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the patient had her vns explanted on (b)(6) 2016 as her incision had broken open. The surgeon was concerned that everything was infected. Originally, it was unknown how the dehiscence occurred; however, it was later found that the patient had fallen on an unknown date, which caused the generator site incision to open. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

 
Event Description

It was later reported that after the patient's device was explanted she began to have an increase in seizures. The increase in seizures was caused by the loss of therapy as the device was explanted due to the infection.

 
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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 Key6036101
Report Number1644487-2016-02390
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/19/2018
Device MODEL Number106
Device LOT Number203837
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/31/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2016
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: 10/18/2016 Patient Sequence Number: 1
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