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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 03/01/2018
Event Type  Injury  
Event Description

It was reported by a patient through social media that she was the first live patient for the surgeon implanting her vns and now had "heart blockage". The patient further stated that she had vns implanted in (b)(6) 2015 and was having heart problems attributed to the vns by (b)(6) 2018. She stated she was seeking vns explant. Programming history was reviewed, however data was only available from the date of implant up to (b)(6) 2016, which noted no device issue. No further relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem, corrected data. Follow up report #1 inadvertently noted "an implant was received for the patient's replacement surgery, which was indicated to be due to battery depletion. " instead of "an implant form was received for the patient's replacement surgery, which was indicated to be due to battery depletion. ".

 
Event Description

An implant form was received for the patient's replacement surgery, which was indicated to be due to battery depletion. It was confirmed that the device was discarded and would not be available to be returned for analysis. Follow up with the physician's office noted that they were never made aware of the reported events and had only seen the patient due to the report of a dead battery that needed replacing, with no other reports. It was stated that since the replacement surgery, the office had still not heard anything from the patient. No additional, relevant information was received to date.

 
Event Description

An incoming voicemail from the patient was received stating that her vns was "floating" in her chest and was making it hard for her to breathe. It was stated that "it hurts like a heart attack". The patient was referred for surgery. An implant was received for the patient's replacement surgery, which was indicated to be due to battery depletion. No device has been received for analysis. No additional, relevant information was 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7889910
Report Number1644487-2018-01647
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/26/2017
Device MODEL Number106
Device LOT Number4374
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/11/2015
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: 09/19/2018 Patient Sequence Number: 1
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