• 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 Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr? no, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

 
Event Description

It was reported that the patient underwent generator and lead explant due to infection and extrusion. Additional information was received that the patient had a infection about 6 weeks after first implant. Patient underwent surgery to clean and flush the area and was provided with antibiotics. About 4 weeks after this surgery, the devices were removed via another surgery due to the wound opening and the generator and lead coming up under the skin. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

 
Event Description

Explanted generator and lead were received. Potential contributing factors to allergic reaction and infection were evaluated and none were found to exist in this situation. The device history record shows that the pulse generator passed all specifications before it was released. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

 
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7650669
Report Number1644487-2018-01097
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 07/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204230
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/06/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2017
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: 06/29/2018 Patient Sequence Number: 1
-
-