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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr? (b)(4). Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

 
Event Description

Report received that a patient developed an infection at the chest incision site within three months of initial implant. The area was debrided and reclosed. A review of the generator device history record indicated it had been sterilized according to specification prior to being released for distribution. No additional relevant information has been received to date.

 
Event Description

Further information was received that the generator incision site opened and the device could be seen. This was reportedly caused by the previous infection that returned. As a result, the generator and lead were explanted. No additional relevant information has been received.

 
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Brand NamePULSE GEN MODEL 104
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 Key7293377
Report Number1644487-2018-00275
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/25/2019
Device MODEL Number104
Device LOT Number204093
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/15/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/19/2017
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: 02/23/2018 Patient Sequence Number: 1
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