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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 08/13/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes were received for referral for replacement. Notes mention that the patient seizures have changed in the last 6 months and her brother noted that the patient¿s memory ¿is going crazy¿ and sometimes she is not able to talk correctly on the phone or in conversation. Directly after mentioning these issues, the discussion of vns replacement was noted. It appears they believe these issues may be associated with vns. The patient also noted more coughing recently and wasn¿t sure if this was related to vns stimulation. The physician¿s ma indicated that she suspects the seizures are vns related. The physician also believes that the patient¿s memory issues and inability to speak correctly is vns related but there was mention that the nonsense in conversation is her seizure presentation. No additional or relevant information has occurred to date. No surgical intervention has occurred 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 Key7853645
Report Number1644487-2018-01567
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/26/2010
Device MODEL Number102
Device LOT Number200784
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2018
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: 09/06/2018 Patient Sequence Number: 1
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