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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 02/15/2018
Event Type  Malfunction  
Event Description

Patient was referred for surgery due to high impedance. Parents could not report any known trauma. The lead and generator were replaced and impedance was within normal limits after replacement. Additional information was received that high impedance was first observed by the neurologist prior to surgery. It is the neurologist's assessment that the lead was fractured based on the lead tightness and lead pin pull out. A lead fracture was not observed by the surgeon. The surgeon also did not visually see the lead pin out of the generator until the lead were removed to replace the generator. Lead fracture is suspected based on the high impedance observed prior to surgery. The explanted lead was received. Analysis is underway and has not been completed to date.

 
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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 Key7541148
Report Number1644487-2018-00856
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number302-20
Device LOT Number1948
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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