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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2016
Event Type  Injury  
Event Description

Clinic notes were received for this patient's reported prophylactic replacement. The clinic notes stated that the patient complained of intermittent swelling and pain in her throat with trouble swallowing, where the issues with swelling and pain have been ongoing for at least 6 months. More recent clinic notes reported that this patient's vns is hurting their neck at the site of her vns lead, at all times. The patient also mentioned that they believed that their vns generator was migrating. It was also indicated that this patient is a smoker, smoking 11-20 cigarettes a day. Additional information was received from the doctor that it was unknown when the migration first occurred, and the migration is suspected, not confirmed. It is unknown what the cause of the suspected migration is, but it is a contributory cause to the patient's surgery referral. It was stated that the surgery for the patient's migration would be due to patient comfort reasons. It was unknown what the cause of the patient's constant pain at the electrode site was, but the pain was a contributory cause for the patient's surgery referral and it was stated that it would be both for patient comfort reasons and to preclude a serious injury. The cause of the patient's swelling in her throat was unknown, but the patient's difficulty swallowing was stated to be occurring with stimulation. The cause of the patient's difficulty swallowing was stated to be related to stimulation, and possibly related to the migration. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key7854914
Report Number1644487-2018-01568
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/27/2012
Device MODEL Number102
Device LOT Number201571
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2010
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: 09/07/2018 Patient Sequence Number: 1
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