• 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 103 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 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/04/2014
Event Type  Injury  
Event Description

It was reported that during sinus surgery on (b)(6) 2014 unrelated to vns, the patient had atrial fibrillation. The patient received a cardiogram at that time and was stabilized. Follow-up revealed that no issues were seen with the patient¿s device and normal mode device settings. It is unknown if the patient¿s device was disabled for the procedure. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Clinic notes were received indicating that the vns patient underwent gallbladder removal surgery and not sinus surgery as initially reported. Three hours following surgery, the patient reported experiencing shooting pain up on the left side of her neck and coughing. Additionally, a lump was located in her left breast below the generator.

 
Event Description

Clinic notes were received stating that the vns patient had been hospitalized the week prior to her office visit on (b)(6) 2014 due to atrial fibrillation and underwent cardioversion in the or. Three hours following surgery, the patient experienced coughing due to shooting pain up the left side of her neck. The magnet was used to temporarily disable the device. The patient¿s device settings were increased following the cardiac events. There was concern that the cardioversion may have somehow altered the patient¿s device settings. The patient subsequently experienced throat irritation at the higher device settings which resolved when the settings were reduced.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4156771
Report Number1644487-2014-02600
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 09/12/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number103
Device LOT Number202252
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/25/2012
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: 10/09/2014 Patient Sequence Number: 1
-
-