• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

A patient reported side effects of extreme pain in the sternum/chest, nausea, difficulty swallowing, and any gas belching can¿t come up. He also reported sharps pains and happens when trying to eat. He also mentioned that he can¿t swallow as if there is a blockage in the middle. He also stated that there is a jolting nerve type of pain going through the left shoulder and biceps where the muscle meets the collar bone. He stated that it doesn¿t happen all that much. A couple of years ago, he also mentioned pain with hiccups, that happened when eating. It used to be hit or miss, but is getting to where can¿t breathe when trying to eat. He stated that the issue was lasting longer than 5 minutes. He stated that there are sometimes when looking to the left, can feel it, but not that often. The patient later reported on (b)(6) 2018 that he had shortness of breath, pain in chest and neck, and has difficulty swallowing. These symptoms started 2 months prior but have gotten worse and the pain was so bad that he went to the er. He reports that he wants the device removed. Additional relevant information has not been received to-date.

 
Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: intervention taken was inadvertently not checked on the initial mdr describe event or problem, corrected data: information about the patient's settings being adjusted due to his symptoms were inadvertently omitted on the initial report.

 
Event Description

It was reported that when the patient followed-up with the physician, his pulse-width and frequency were adjusted as a result of the symptoms. The patient reportedly said that he could only eat standing up due to these issues. Per the doctor, the patient's events were related to stimulation since they stopped when the magnet was taped on, but that the doctor didn't know why it suddenly started after the patient was fine for a few years after implant. Reportedly, there was an incident where the patient worked and he was grabbed by the neck during an altercation the doctor wondered if this might be related to the patient's symptoms. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 105
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 Key7827569
Report Number1644487-2018-01519
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/04/2015
Device MODEL Number105
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/29/2018 Patient Sequence Number: 1
-
-