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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 03/21/2016
Event Type  Malfunction  
Event Description

It was reported that patient's device was showing eos yes after only being implanted for two years. The patient¿s settings were still at 0ma due to the eos pulse disablement. A review of device history records for the generator shows that no unresolved non-conformances were found. Internal investigation determined that this behavior was likely related to an increased duration of the high battery impedance experienced by batteries during the beginning of life (bol) or an internal short that managed to ¿burn¿ itself out.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7920766
Report Number1644487-2018-01725
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/28/2017
Device MODEL Number106
Device LOT Number203833
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/21/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/28/2018 Patient Sequence Number: 1
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