• 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 106; 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 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Paralysis (1997); Neck Pain (2433); No Information (3190); No Code Available (3191)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the sales representative that the patient went to the er.It was noted that the patient was experiencing painful stimulation and their device was programmed off.It was noted that the patient had not been interrogated in a year.The patient was seen and attempted to have their device programmed on.The patient had a coughing fit, voice alteration and painful stimulation.The patient pain was reported to start at the neck and goes up to the ear.It was noted by the patient that the emergency room physician said that the patient may have vcp.No known surgery has occurred to date.No additional relevant information has been received to date.
 
Manufacturer Narrative
F10.Event problem codes - patient code - correction - code 3190 was inadvertently reported in the initial mdr, however the event of coughing and voice alteration should have been captured with the code of 3191 - no code available.F10.Event problem codes - patient code - correction - code 1994 should have been reported in the initial mdr for the event of ear pain.H6.Evaluation codes - conclusions - correction - code 22 should have been included in the initial mdr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key10536306
MDR Text Key207026165
Report Number1644487-2020-01213
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2018
Device Model Number106
Device Lot Number203931
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received09/15/2020
Supplement Dates Manufacturer Received10/08/2020
Supplement Dates FDA Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age58 YR
-
-