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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 Problems Corroded ; Fracture; High impedance; Mechanical Problem; Low impedance
Event Date 12/08/2018
Event Type  Malfunction  
Event Description

It was reported that high impedance was seen on patient's device. It was noted that during a previous follow-up visit, the physician observed low lead impedance. No other relevant information has been received to date. There has been no known surgical intervention to date.

 
Event Description

X-rays were taken and provided for review. The x-rays indicated that the generator was located in the patient¿s upper left chest. The connector pin can be seen coming through the second connector block. The filter feedthru were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins. A gross discontinuity was identified in the visible portion of the lead near one of the tie downs in the patient¿s neck, and the second coil at the same location appeared to be bent at a sharp angle. The cause of the patient¿s impedance issue is likely due to the observed gross discontinuity. It was reported that the patient¿s lead and generator were explanted. The explanted products have not been received by the manufacturer to date. No further relevant information has been received to date.

 
Event Description

The explanted lead and generator were received for product analysis. The lead underwent product analysis and was approved on 4/24/2019. During the visual analysis, the coil was observed to be broken in two locations. Pitting and residual material was observed on the coil surface. It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded opening found on the outer silicone tubing and connector ring inner silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and connector ring inner silicone tubes. With the exception of the observed discontinuity and abraded openings the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device. The pulse generator underwent product analysis and various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. 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 conditions found with the pulse generator. No other 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 Key8266360
Report Number1644487-2019-00110
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203912
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/08/2016
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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