• 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. PULSE GEN MODEL 105 GENERATOR

  • 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. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Insufficient Information
Event Date 07/18/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, it was reported that since the patient's vns revision surgery, the patient's voice has gone out. There were no further details on what this meant besides that the patient's voice got hoarse and the patient lost her voice temporarily. It was unknown whether this was with stimulation or not. The patient also had pneumonia after the surgery; however, the relationship to vns was unknown. Additional information was received that testing found the patient had some "sleepiness" of the left vocal cord. Per the physician, the pneumonia was likely related to the vocal cord not working as it probably allowed the patient to aspirate, causing the pneumonia. On the one month post-op visit, the physician noted that the wounds had healed nicely at that time. The patient was quite hoarse after surgery. Examination of the vocal cords indicated decreased mobility of the left vocal cord. It was noted that the vocal cord was not paralyzed, but had decreased mobility. The patient was experiencing mild aspiration. The physician gave the patient swallowing tips and recommended potential further action if the event did not improve; however, he was hopeful for resolution as there was some mobility. No additional information has been provided.

 
Event Description

Additional information was received that the surgeon did a procedure to treat the vocal cord paralysis and not the patient is experiencing an increase in seizures. At this time the surgeon does not know the cause of the increase in seizures. No other information was provided.

 
Event Description

The physician indicated that the decreased motility of the vocal cord is probably related to vns therapy. The physician was unsure if the decreased motility of the vocal cord occurred with stimulation. The physician reported that the pneumonia has resolved and that the vocal cord paralysis is presumed to persist as her dysphonia has persisted.

 
Event Description

The patient was to follow-up with orl surgeon. Upon further follow-up with regards to the seizures, the physician did not think the seizures have increased. The patient¿s seizures are noted to be occasional.

 
Manufacturer Narrative

 
Manufacturer Narrative

Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date.

 
Manufacturer Narrative

The supplemental report #3 inadvertently did not report this information from the physician.

 
Event Description

Clinic notes dated (b)(6) 2015 reported in the history of present illness that since the vns has been placed, the patient has developed some vocal cord problems and was seeing an ent. No vns programming changes were made.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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 Key3322853
Report Number1644487-2013-02598
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number105
Device LOT Number3620
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2013
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: 09/03/2013 Patient Sequence Number: 1
-
-