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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
Event Date 08/09/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a patient had low impedance results on his first follow-up visit following initial implant. Two system diagnostics were performed and showed low impedance. There was reportedly no trauma that had occurred since implant, but the patient reportedly felt a "heat sensation all day" at one point. The patient reported that they had still experienced coughing when the settings were increased. It was noted that impedance values were intermittently within normal limits pre-operatively. When the patient's position changed, he sometimes got impedance values in normal limits and other times got low impedance. The physician reported that he saw a "bubble" in the connector cavity that he believed was causing the low impedance. The surgeon opted to perform generator replacement and leave the lead intact. The explanted generator has not been received to date. No further relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently did not include information regarding post generator replacement. Relevant tests/laboratory data, including dates: the initial report inadvertently did not include the post generator replacement impedance value.

 
Event Description

After the patient's generator replacement surgery on (b)(6) 2016, the impedance values were within normal limits. It was reported that the explanted generator would not be returned for analysis per the explant facility's policy. X-rays were provided to the manufacturer for review. The a/p chest x-ray showed that the lead pin was fully inserted into the connector block, the feedthru wires appeared intact at the connector block, and the generator was placed normally in the left chest just below the clavicle. A portion of the lead was found routed behind the generator. No gross lead discontinuities were identified, no sharp angles were identified, and the lead appeared intact at the connector pin. An assessment could not be made on the portion of the lead routed behind the generator. Therefore, the presence of a microfracture and any additional information regarding the lead portion behind the generator cannot be assessed. No additional relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: supplemental report #1 inadvertently did not include notice that the generator had been returned.

 
Event Description

The explanted generator was returned for analysis. Historical diagnostic data was also provided and reviewed. Historical found the date that the low impedance message was first identified and verified that the impedance had bounced back up as previously reported to about 2,000 ohms at one time. The explanted generator is currently undergoing analysis.

 
Event Description

The explanted generator was returned and had product analysis completed, verifying that the generator was able to accurately measure impedance values. This verified that there was an intermittent short circuit in the lead. Negative impedance values were measured when there was a 0 ohm load applied to the generator.

 
Event Description

Full analysis was completed on the generator and confirmed its ability to accurately measure impedance values. The device was placed in a simulated body environment and the generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The generator was subjected to multiple electrical loads and verified the ability to accurately measure impedance values within an appropriate range. The generator septum was visually analyzed and verified that it was not cored. No other surface anomalies were identified on the generator. The generator performed according to all functional specifications with respect to accurately measuring impedance values.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5950353
Report Number1644487-2016-02078
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup
Report Date 07/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2016
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 Number4553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/08/2015
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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