Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 1000; 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 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Pain (1994)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was admitted to the hospital due to coughing, pain in the neck and chest, and a syncope event.The patient was admitted with the magnet taped over the generator to disable stimulation.It was later reported that the physician was unsure of what the cause of the syncope event was.It was reported that the patient was also struggling with difficulty breathing.The physician was also unsure of the cause of the difficulty breathing.No additional relevant information has been received to date.
 
Manufacturer Narrative
D4 - suspected medical device unique identifier (udi) # - corrected data: inadvertently used incomplete udi on initial submission.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key10732237
MDR Text Key212969974
Report Number1644487-2020-01429
Device Sequence Number1
Product Code LYJ
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 12/07/2020
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 Date03/31/2022
Device Model Number1000
Device Lot Number205270
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 09/28/2020
Initial Date FDA Received10/25/2020
Supplement Dates Manufacturer Received11/12/2020
Supplement Dates FDA Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
-
-