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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 Date 07/04/2018
Event Type  Injury  
Event Description

It was reported that surgery was being taken to reposition the patient's generator as the generator had migrated to an axillary position. It was also reported that the generator had been replaced recently and since there had been issues with wound healing and the wound had opened. No additional or relevant information has been received to date.

 
Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

 
Event Description

It was reported that the patient was implanted with another m106 generator prior to the current generator, and the migration and wound reopening (stated in the previous report) occurred with this generator implanted. It was also reported that the patient had developed an infection after being implanted with this initial m106 generator. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release and it was verified that the device was sterilized prior to distribution. No additional or 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 Key7726467
Report Number1644487-2018-01304
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204379
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/17/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/09/2018
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: 07/27/2018 Patient Sequence Number: 1
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