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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 12/13/2017
Event Type  Injury  
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 a vns patient was scheduled for explant of the generator and lead. The reason was later provided from the notes that it was because the vns incision has opened and is draining pus. Review of the manufacturing records for the generator and lead confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Event Description

Clinic notes were later received providing that the device had been removed due to the infection on (b)(6) 2018.

 
Manufacturer Narrative

Date of event, corrected data: the event date was inadvertently provided incorrectly on the initial report. Event description, corrected data: the date of explant was inadvertently provided incorrectly on the event description in follow-up report#1.

 
Event Description

Clinic notes were received providing that the device had been removed due to the infection on (b)(6) 2018.

 
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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 Key7287555
Report Number1644487-2018-00257
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5386
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/28/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/08/2017
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: 02/21/2018 Patient Sequence Number: 1
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