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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 Problem Premature End-of-Life Indicator
Event Date 11/06/2018
Event Type  Malfunction  
Event Description

It was reported that a patient's device was suspected to be at end of service condition as the device could not be interrogated despite several different programming systems attempting interrogation. The patient was referred for battery depletion. A battery life calculation was performed and did not support the allegation of the device reaching end of service condition. The patient's husband believed the device had prematurely depleted. It was noted that the patient was last seen in (b)(6) by the epileptologist however the device was not interrogated at this appointment. A review of the device history record indicated that the generator had been laser-routed which has been shown to produce excess debris on the circuit board. This debris may lead to excess current draw from the generator, which can deplete the battery prematurely. No battery replacement surgery had occurred to date. No additional, relevant information was received 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 Key8123316
Report Number1644487-2018-02184
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/20/2017
Device MODEL Number106
Device LOT Number203437
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2015
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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