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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 06/11/2015
Event Type  Malfunction  
Event Description

It was initially reported that this patient's generator was on the list of suspected devices that were laser routed. The physician therefore requested data analysis as a generator replacement was needed only about 3 years after the generator was implanted. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. The device met all specifications for release prior to distribution. Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths. Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected. The patient received a generator replacement, and the explanted product has been received by the manufacturer where analysis is underway but has not been completed to date. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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 Key8124214
Report Number1644487-2018-02191
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/01/2017
Device MODEL Number105
Device LOT Number4274
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/11/2015
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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