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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient has drainage at the vns site. The patient was referred to the surgeon for evaluation. Review of device manufacturing records for the generator confirmed sterilization prior to distribution. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date. The patient had undergone generator replacement in (b)(6) 2015 due to wound dehiscence (mfr. Report # 1644487-2015-03969).

 
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Brand NamePULSE GEN MODEL 105
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 Key5682344
Report Number1644487-2016-01143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/02/2016
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 Date08/08/2016
Device MODEL Number105
Device LOT Number4033
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/17/2014
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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