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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR
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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 (2993)
Patient Problem Chest Pain (1776)
Event Date 04/21/2021
Event Type  Injury  
Event Description
It was reported that the patient had been in the hospital with chest pain.The patient reported that a physician at the hospital told them their pain was due to vns therapy.No additional relevant information has been received to date.
 
Event Description
The physician reported that the pain is related to vns (although unclear exactly how and clarification was not able to be obtained to date).It was also noted that other intervention for the pain were being taken.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 105
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11791811
MDR Text Key249517773
Report Number1644487-2021-00628
Device Sequence Number1
Product Code MUZ
UDI-Device Identifier05425025750054
UDI-Public05425025750054
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,consum
Type of Report Initial,Followup
Report Date 06/09/2021
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 Date02/23/2017
Device Model Number105
Device Lot Number4293
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received05/07/2021
Supplement Dates Manufacturer Received05/19/2021
Supplement Dates FDA Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
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