• 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 Adverse Event Without Identified Device or Use Problem
Event Date 08/24/2015
Event Type  Injury  
Event Description

It was reported that the patient was admitted to the er due to painful stimulation at the chest vns generator site. System diagnostics were run and were within normal limits including impedance which was 1888 ohms. It was reported that the patient had a sternal rub the day before and the pain has been occurring since then. Settings were reported as 1/75/20/500/60/1. 8, 2/60/500. The device was then disabled.

 
Event Description

Additional information was received that the patient saw his neurologist one day following the er visit. The neurologist adjusted the vns settings, which reportedly resolved the patient's pain. The physician believed the pain was simply related to normal vns stimulation. The setting adjustment was reportedly performed for patient comfort, not to preclude a serious injury. No additional relevant information has been obtained to date.

 
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 Key5082511
Report Number1644487-2015-05801
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 08/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number105
Device LOT Number3632
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/08/2013
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: 09/16/2015 Patient Sequence Number: 1
-
-