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

MAUDE Adverse Event Report: LIVANOVA USA, 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
 

LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Appropriate Term/Code Not Available
Event Date 12/18/2018
Event Type  Malfunction  
Event Description

It was reported during a generator replacement surgery due to painful stimulation, indicated to be for patient comfort and not to preclude a serious injury, that a dark spot was seen on the generator being explanted. The surgeon stated the spot may have been due to the device being hit with bovie, a form of electrocautery, however he was unable to confirm this. The explanted generator was shipped back for analysis and received. It was confirmed that the pre-operative diagnostics and settings were within normal limits. Follow-up with the patient's neurologist also noted ok diagnostics prior to surgery. The implant card was received for the surgery indicating the surgery was prophylactic. Analysis of the returned generator has not been completed to date. No additional, relevant information was received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8304846
Report Number1644487-2019-00232
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/22/2018
Device MODEL Number106
Device LOT Number4822
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/19/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-