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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 05/05/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient's generator incision was not healing well following replacement surgery and that the incision was open. The patient underwent an outpatient procedure where the incision was found to be small and superficial. No vns product was exposed. The incision was cleaned and sutured closed. Since the outpatient procedure the surgeon reports that the incision is healing well. Review of device manufacturing records for generator confirmed sterilization prior to distribution.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5682673
Report Number1644487-2016-01148
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Report Date 05/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/04/2018
Device MODEL Number106
Device LOT Number4697
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2016
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: 05/26/2016 Patient Sequence Number: 1
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