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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 01/06/2019
Event Type  Malfunction  
Event Description

It was reported that high lead impedance was found while the patient was in the clinic and suspected to be a lead break. Output current was stated to be low. Patient had consult with surgeon and scheduled lead revision surgery. Information was received confirming the revision surgery took place. It was stated that during the replacement case, the lead pin was found in the generator cavity and the silicone portion of the lead was detached from the lead pin. Surgeon located the generator and found that it was not attached to the lead. Both the generator and lead were replaced. It was stated both the generator and lead would be sent back for analysis, but has not been received to date. It was stated that the wires were not abraded and was a clean detachment from the pin. It was also stated that there was no known trauma to the area and physician does not know what could have caused this. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8658057
Report Number1644487-2019-01026
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/11/2016
Device MODEL Number304-20
Device LOT Number202308
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/06/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/15/2012
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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