• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The patient had previously underwent a generator explant surgery due to an infection which developed shortly after the generator was implanted. This infection is reported on mfr. Report #1644487-2018-02229. Additional information was received which reported the patient had also developed speech difficulties and trouble swallowing after the implant surgery. It was also reported that the patient¿s swallowing and speech became worse after the device was removed due to the infection. The patient was evaluated by an ent specialist who diagnosed the patient with vocal cord paralysis. The ent's evaluation of the patient determined that, per a laryngoscopy, the left vocal cord was frozen in the paramedian position. Additionally, the patient experienced dysphonia and dysphagia following the vns removal in addition to the diagnosed vocal cord paralysis. The ent was also concerned the patient was aspirating liquids and requested a swallow test. Furthermore, during the swallow test the patient aspirated a small amount of thick liquid. Per the ent's specialist, the vocal cord paralysis is likely associated with the removal surgery. No additional or relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key8381913
Report Number1644487-2019-00386
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/28/2010
Device MODEL Number302-20
Device LOT Number200417
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2007
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: 03/01/2019 Patient Sequence Number: 1
-
-