• 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. LEAD MODEL 302

  • 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. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 01/01/2018
Event Type  Malfunction  
Event Description

It was reported that a pediatric patient suffered from an increase in number of epileptic seizures and pain in the chest region. Physicians expected a problem and ordered an x-ray on which no breakage or other abnormality could be diagnosed. The neurosurgeon decided to surgically explore during which they could visually see a breakage. The lead was replaced. High impedance was reported to be observed before the surgery and the physician mentioned that no trauma or fall happened to the patient. The explanted lead has not been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key7569971
Report Number1644487-2018-00942
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device MODEL Number302-20
Device LOT Number201993
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/12/2012
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: 06/05/2018 Patient Sequence Number: 1
-
-