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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 07/01/2014
Event Type  Injury  
Event Description

Clinic notes were received for the patient's planned generator replacement due to battery depletion. In the notes, it was reported that the patient previously ascribed intermittent chest pain to the vns, and now the physician believes it may be in part due to the patient's gerd. Per the physician, the generator is likely contributing to the patient's pain, though it is uncertain if it is due to stimulation or the presence of the device. The patient underwent generator replacement. No additional relevant information has been received to date. The generator has not been received by the manufacturer 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 Key8002204
Report Number1644487-2018-01882
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/13/2014
Device MODEL Number102
Device LOT Number3377
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/19/2012
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: 10/24/2018 Patient Sequence Number: 1
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