• 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 Muscle Weakness (1967); Dizziness (2194); Ambulation Difficulties (2544)
Event Date 04/16/2021
Event Type  Injury  
Event Description
The patient recently had prophylactic generator replacement and was set to the same settings as before the surgery.Following the surgery, he reported having episodes of falling, like all of a sudden he would lose strength, get light headed, and fall over.It was noted that during the patient's follow-up appointment, the magnet was swiped and the patient fell over as described.They were not sure if the vns was causing the issues but disabled it just in case.They had hypothesized that the patient could be having bradycardic episodes but bradycardia was not confirmed.It was noted by the physician that the patient was experiencing a sudden near faint like feeling that is not seizure-like or associated with postictal symptoms.Per the physician, the cause of the faint-like episodes is due to underlying health condition and worsened by vns.The device was turned back on.No further relevant information has been received to date.
 
Manufacturer Narrative
H10.Corrected data, initial report: should have used health effect code e1621 for muscle weakness rather than e2302 for ambulation difficulties.
 
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 Key11826259
MDR Text Key250669400
Report Number1644487-2021-00663
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
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 08/09/2021
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 Date08/18/2022
Device Model Number1000
Device Lot Number205394
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received05/14/2021
Supplement Dates Manufacturer Received08/09/2021
Supplement Dates FDA Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age25 YR
-
-