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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 10/30/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

 
Event Description

Patient underwent vns generator explant due to an infection. The patient presented with post-surgical fever and edema in the thoracic region that was unable to be treated with antibiotics. A swab was collected from the generator and showed staphylococcus aureus. When the event was reported, it was noted that the implant facility was closed for an anvisa audit due to an increase in hospital infections. Review of the generator and lead device history records confirmed sterility prior to distribution. No other relevant information has been received to date.

 
Event Description

The infection was confirmed to only be at the generator site. The lead was reported to not have been removed.

 
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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 Key8214393
Report Number1644487-2019-02406
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 01/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number106
Device LOT Number204541
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/07/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/11/2018
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: 01/03/2019 Patient Sequence Number: 1
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