• 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 106 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 106 GENERATOR Back to Search Results
Model Number 106
Device Problem High impedance
Event Date 08/09/2017
Event Type  Malfunction  
Event Description

Report was received that high impedance was found in the operating room. The patient was receiving a full revision surgery. After the old generator and lead were removed, a new generator and lead were implanted. Prior to the conclusion of surgery, system diagnostics were run on this system and resulted in high impedance. Proper pin insertion was reportedly verified and the nerve was irrigated. Generator diagnostics were performed using a test pin and the results returned were normal. The surgeon decided to try another lead, but the surgeon reportedly had difficulty placing the electrodes on the lead. Prior to completing the surgery, the patient began to show signs of arrhythmia (captured in mfr. Report #1644487-2017-04402) the anesthesiologist reportedly recommended that the surgery be terminated because the arrhythmia was likely related to vagus nerve manipulation in conjunction with duration under anesthesia. The patient returned for surgery at a later date to complete the lead revision, but it was found that vagus nerve was attached to the jugular vein by scarring. The scarring could not be dissected and the lead revision could not be completed. The device history record was reviewed and showed the lead passed all quality specifications prior to release for distribution. No known surgical intervention has been completed to date. No further relevant information has been received to date.

 
Event Description

Product analysis was completed and approved on the lead. The condition of the electrodes and helices were consistent with conditions that typically exist after manipulation during an attempted implant. Three half sets of set screw marks were found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. There was no dimensional issue found in the connector portion of the lead which would have prevented it from being inserted into the generator. Continuity checks were performed and no discontinuities or fractures were identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. No further information has been received to date.

 
Event Description

Further information was received that the patient had an implant surgery where a new lead was successfully implanted. Additionally, the implanted generator was replaced with a new generator as the surgeon did not want to use the generator that had been implanted without connection to any lead. The generator has not been received to date. No further relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 106
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 Key6843758
Report Number1644487-2017-04401
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/11/2019
Device MODEL Number106
Device LOT Number204051
Was Device Available For Evaluation? No
Date Returned to Manufacturer08/31/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-