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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR
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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 Problem Arrhythmia (1721)
Event Date 01/18/2021
Event Type  Injury  
Event Description
The physician reported that the patient had been experiencing low heart rate and that a cardiologist recommended trying to turn off the vns device, therefore the device was disabled.No other relevant information has been received to date.
 
Event Description
Information was received from the physician that after turning off the device for 2 weeks there was no change in heart rate, so the vns was turned back on as the arrhythmia was determined to be unrelated to the vns.No other relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11276789
MDR Text Key230231469
Report Number1644487-2021-00152
Device Sequence Number1
Product Code MUZ
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 health professional
Type of Report Initial,Followup
Report Date 03/04/2021
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 Date10/10/2020
Device Model Number106
Device Lot Number204693
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 01/18/2021
Initial Date FDA Received02/03/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received03/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
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