• 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. BIPOL LEAD MODEL 300

  • 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. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/01/2012
Event Type  Injury  
Event Description

It was reported by the physician on (b)(6) 2012 that the patient had developed vocal cord paralysis in (b)(6) 2012. The patient was last seen in (b)(6) and diagnostics at that time were within normal limits with an impedance value of 2571ohms. The patient saw another physician who indicated that the patient had left vocal cord paralysis. The physician feels that the paralysis is related to vns. No trauma or manipulation to device was reported and there had been no change in the patient's settings. The generator was left on. The patient had also experienced idiopathic right vocal cord paralysis. He had a tracheostomy and the airway is protected. The patient was being seen again by the physician where he planned to re-perform diagnostics. Additional follow up was performed with the physician. It was indicated that the physician could not explain how after years of safe and tolerated stimulation, this patient would suddenly develop dual vocal cord paralysis, but stated that vns must be the cause. The patient also developed pneumonia in (b)(6) and saw an ent for the vocal cord issue. The paralysis was not occurring with stimulation and he had no history of vocal cord paralysis prior to implant. The diagnostics which were performed were again within normal limits and the physician decreased the duty cycle and lowered the patient's output current. Results of the ent evaluation were pending.

 
Event Description

Additional information was received from the ent. It was indicated that it was unclear if there was an actual growth on the voice box, however he stated that if there was, it was likely not related to vns. The ent stated that it was possible that the paralysis was related to vns, but indicated that it was unclear if the paralysis was occurring with stimulation on times, if there had been any manipulation or trauma, or if there were any programming or medication changes which preceded the events. The ent noted that the patient had not returned for follow up care, and the he was unaware of any prior history for this patient.

 
Event Description

Additional information was received, in the form of an ent evaluation, on (b)(6) 2012. The ent noted that the patient presented with respiratory insufficiency and hoarseness, but described the symptoms as mild. It was noted that the left vocal cord was immobile. Additionally it was noted that there was a questionable growth in the area of the voicebox. The patient was referred for a direct laryngoscopy esophagoscopy and biopsies. Attempts for additional information from the ent physician have been unsuccessful to date.

 
Event Description

It was reported that the patient's vocal cord paralysis may have been caused by the patient's pneumonia that developed in (b)(6) 2012.

 
Manufacturer Narrative

Additional information was received which corrects the date of event. This report is being submitted to correct this information. Additional information was received which corrects the date of event. This report is being submitted to correct this information.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2772553
Report Number1644487-2012-02513
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2003
Device MODEL Number300-20
Device LOT Number2408
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/11/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/26/2001
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: 10/04/2012 Patient Sequence Number: 1
-
-