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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 08/21/2015
Event Type  Malfunction  
Event Description

It was reported that the patient's battery status indicated 11-25% remaining, and there was a concern his generator had prematurely depleted. Per a review of the manufacturer's device history records, the generator passed final quality and functional specifications prior to release. The generator was laser-routed. A review of the generator's internal data verified premature battery depletion. The generator's voltage indicated that the generator had 11-25 % of its battery life remaining; however, this is inconsistent with the % battery consumed value of 27. 789%, which indicates that around 70% of the battery life should be remaining. From a previous internal investigation, it is known that some laser-routed devices may be susceptible to premature battery depletion. The observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in current leakage paths and premature depletion. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

 
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Brand NamePULSE GEN MODEL 106
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8162718
Report Number1644487-2018-02290
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/14/2017
Device MODEL Number106
Device LOT Number203806
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2015
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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