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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 Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient was experiencing generator migration in the breast and armpit areas, protrusion, and pain to the point where it was noticeable. The generator was believed to have either never been secured, or the stitch had broken. The generator was also larger than her previous model. No surgical intervention to correct the migration/protrusion has occurred to date.

 
Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

 
Event Description

The patient had surgery due to the generator migration. The patient was very small, and the device was very bulky for the patient's size, so the device was replaced prophylactically. It was unknown if the generator had ever been sutured down or if the suture had broken. 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7517351
Report Number1644487-2018-00789
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/20/2017
Device MODEL Number106
Device LOT Number4365
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/25/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/04/2015
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: 05/15/2018 Patient Sequence Number: 1
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