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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 12/14/2018
Event Type  Malfunction  
Event Description

It was reported by the patient's physician that their generator had depleted to 25% since their replacement surgery on (b)(6) 2018. The physician indicated that the patient's generator had depleted quicker than expected, and that the patient was programmed to high settings and used the magnet with each seizure. A review of the device history records for the generator showed that no unresolved non-conformances were found and that the device met all specifications for release prior to distribution. The manufacturer's battery life calculation tool indicated that if the patient was set to the highest setting since implant, a 25% battery status indicator is possible. It was reported that the patient experienced an increase in seizure frequency and that their seizures were occurring at a different time of the day. The physician indicated that the patient's seizure frequency can fluctuate. The physician indicated that the patient's increase in seizures was worse than their pre-vns seizure rate baseline and the patient's mother indicated that no external factors were involved. The physician indicated that the patient's seizures were either related to low battery or was not related to the vns. No known surgical intervention has occurred to date. No further relevant 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 Key8229152
Report Number1644487-2019-00036
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204358
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/30/2018
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: 01/08/2019 Patient Sequence Number: 1
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