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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/22/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Report was received that a patient had experienced left facial drooping after a lead replacement surgery dye to a lead fracture as reported in mfr. Report #1644487-2017-03897. The patient's left eye also appeared smaller than her right eye. The physician reportedly did not observe these characteristics when the patient returned for a follow-up appointment after the initial report. The system diagnostic test after the patient's lead replacement surgery was within expected limits. A review of the dhr indicated the device was properly sterilized and passed all quality inspections prior to release for distribution. No other relevant information has been received to date.

 
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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 Key6664531
Report Number1644487-2017-04028
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/02/2019
Device MODEL Number106
Device LOT Number204037
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2017
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: 06/23/2017 Patient Sequence Number: 1
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