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

MAUDE Adverse Event Report: CYBERONICS, INC. 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, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 01/31/2018
Event Type  Malfunction  
Event Description

Report received that a patient was seen in the clinic and reported experiencing a lack of perception of vns stimulation, an increase in depression symptoms, and a deepening of her voice during stimulation. The vns was interrogated and high impedance was observed. The clinic notes from this visit were also reviewed and indicated that the patient had a worsening of depression symptoms especially over the few weeks prior to this appointment. The patient's husband was reportedly concerned that the vns was not working properly. No surgical intervention has occurred to date. No additional relevant information has been obtained.

 
Event Description

Further information was received that the patient's vns lead and generator were replaced. The explanting hospital reportedly discards products after explant so the devices were not returned to the manufacturer. No additional 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, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7341801
Report Number1644487-2018-00374
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/09/2008
Device MODEL Number302-20
Device LOT Number1334
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2005
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: 03/15/2018 Patient Sequence Number: 1
-
-