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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

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LIVANOVA USA, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 05/06/2018
Event Type  Malfunction  
Event Description

High lead impedance was observed on a patient's vns system during a follow-up visit. The physician elected to perform surgery to replace the patient's generator, as the battery was low, and planned to replace the lead upon evaluating its status at surgery. X-ray images were taken of the system prior to surgery, but the physician did not observe any lead discontinuities in the images. Upon explanting the generator during surgery, the physician observed that the lead was tangled and decided to replace the lead also. The physician observed a fracture in the lead after it was explanted. The physician reviewed the x-ray images again and observed that the fracture was actually visible in the images. The physician was unsure whether patient manipulation contributed to the lead fracture. X-ray images from several clinic visits were received by the manufacturer, but have not been reviewed to date. The explanted lead and generator have not been received by the manufacturer to date. No additional relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently indicated the incorrect device disposition. Device available for evaluation? corrected data: initial report inadvertently indicated the incorrect device disposition. Device evaluated by mfr?, corrected data: initial report inadvertently indicated the incorrect device disposition.

 
Event Description

The received x-ray images were reviewed by the manufacturer. The lead was observed in the neck and chest. But the lead did not appear to be routed behind the generator the images from 2018. Due to the quality of the images provided, it was difficult to assess the continuity of the lead. A gross fracture was visualized midway between the electrodes and the generator in the patient¿s left chest in the images after the high impedance was identified. The lead also appeared fractured after a coiled part of the lead near the base of the connector pin. The lead wires appeared to be intact at the connector pin in each of the images. The explanted lead and generator were received by the manufacturer for product analysis. Analysis was approved on the returned generator. The data downloaded from the generator showed that high impedance was present at least 1 month prior to the physician's observation of high impedance. Electrical testing of the internal circuitry confirmed 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. Analysis has not been approved for the returned lead to date. No additional relevant information has been received to date.

 
Event Description

Analysis was approved for the lead. The lead was returned in two pieces. Two sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. The overall appearance of the lead was consistent with patient manipulation of the device. A lead break was observed in the positive and negative lead coils, and microscopy identified pitting at the location of the lead break. Abraded openings were observed along the body of the lead, and fluid was observed inside the tubing at these locations. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 303
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 Key7753753
Report Number1644487-2018-01338
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2017
Device MODEL Number303-20
Device LOT Number3738
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/10/2013
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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