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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 06/14/2016
Event Type  Malfunction  
Event Description

It was reported by the patient's mother that she believed that the device was prematurely depleting, as the patient's battery was at low after being implanted for two years. Device history records were reviewed for the generator. The device was laser routed, indicating that they are potentially subject to premature end of life. Programming history was reviewed for the patient. Battery voltage consumed and the actual battery voltage did not match, indicating that the device was prematurely depleted. No other anomalies were seen. Surgery is likely but has not occurred to date. No additional information has been 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 Key8258571
Report Number1644487-2019-00086
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/24/2017
Device MODEL Number106
Device LOT Number203824
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age5 yr
Event Location Other
Date Manufacturer Received01/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/14/2016
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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