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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/27/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient's generator has moved laterally almost into the axilla and is causing itching and pain. Information was obtained from the implanting physician that absorbable sutures, 2. 0 prolene, were used during the implant procedure. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key7994752
Report Number1644487-2018-01891
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/23/2016
Device MODEL Number103
Device LOT Number4123
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/11/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/23/2014
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: 10/23/2018 Patient Sequence Number: 1
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