• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON 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 - HOUSTON PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient underwent vns generator explantation surgery as it was noted that the patient had a non-functioning device. The patient's lead was reported as still implanted. No additional relevant information has been received to date.

 
Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

 
Event Description

Follow up with the physician's office revealed that the vns was functioning. However, the patient was complaining of pain to the left chest area and the vns generator had migrated down into the left breast.

 
Event Description

Follow up with the physician's office revealed that there was no known trauma or patient manipulation that could have contributed to the pain or migration. It was reported that the surgical intervention was for the patient's comfort.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6975426
Report Number1644487-2017-04673
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number105
Device LOT Number202303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/29/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/12/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-