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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 (2993)
Patient Problems Paralysis (1997); No Code Available (3191)
Event Date 03/20/2019
Event Type  Injury  
Event Description
The patient reported voice hoarseness from intubation at the first follow up appointment post vns implant surgery.It was also noted that the patient experienced vocal cord paralysis, which the physician reported to be related to the vns implant procedure.No other relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8580843
MDR Text Key144092314
Report Number1644487-2019-00861
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/26/2019
Device Model Number106
Device Lot Number204281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received05/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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