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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported from the patient that she had high blood pressure after surgery. She took blood pressure pill and it got better. She also says the incision came apart at some point, but was put back together. It is unclear which incision she is referring to. She states her incision on her chest is red and swollen. No additional or relevant information has been received to date.

 
Event Description

The physician stated that the patient has a history of anxiety, depression and obsessive compulsive disorder. For the allegation that the incision site had opened up post-surgery, he stated that it did not and the patient did not go back to surgery for this. The physician indicated no infection and healing well when asked about the redness and swelling at the generator site. Patient reported she was doing well post op (b)(6) 2018. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7566864
Report Number1644487-2018-00927
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204373
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/29/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/09/2018
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: 06/04/2018 Patient Sequence Number: 1
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