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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 09/02/2018
Event Type  Death  
Event Description

It was reported that the patient was hospitalized after being found in a coma. In the hospital it was reported that he was in a bad state and had thrombocytopenia. The patient had reported the day prior to hospitalization that he felt stimulation in his left neck when bending down. The physician in charge of the patient at the hospital was not sure whether the symptoms and current state of the patient could be related to vns. The manufacturer's device history records of the patient's generator was reviewed. The generator passed final quality and functional specifications prior to release. No further relevant information has been received to date.

 
Event Description

It was reported that the patient passed away approximately two months after the onset of the coma. The attending doctor believed that the death was likely caused by cerebral ischemia with anoxia. No further 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 Key7923538
Report Number1644487-2018-01736
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2018
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/11/2019
Device MODEL Number102
Device LOT Number5269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2017
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: 10/01/2018 Patient Sequence Number: 1
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