• 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
Event Date 09/27/2016
Event Type  Injury  
Manufacturer Narrative

Suspect medical device udi: (b)(4).

 
Event Description

It was reported that the patient was having his vns generator explanted due to infection. Further follow-up found that the patient presented with purulent drainage at the generator site. The patient underwent a wound cleaning procedure for the infection however the surgeon then elected to remove the generator. The lead was cut and the portion of the lead with the electrodes was left implanted. Samples from the infection were sent to the microbiology lab however the results from the microbiology testing have not been received to date. Manufacturing records for the generator were reviewed and it was noted that it was sterilized prior to distribution. No additional relevant information has been received to date.

 
Manufacturer Narrative

Corrected data: evaluation codes: this information was inadvertently reported incorrectly on mfg. Report 0.

 
Event Description

It was reported that the patient had presented with a dehiscence wound several months after the device had been explanted due to infection. The wound had not completely healed and he was placing vaseline on the wound. No additional 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 Key6053715
Report Number1644487-2016-02463
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/03/2018
Device MODEL Number106
Device LOT Number203745
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/04/2016
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: 10/25/2016 Patient Sequence Number: 1
-
-