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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 Convulsion, Clonic (2222)
Event Date 12/03/2021
Event Type  Injury  
Event Description
Patient reported experiencing an increase in seizures recently and is wanting to have her battery replaced asap.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.
 
Event Description
The explanted generator was received but product analysis is still underway.
 
Event Description
Product analysis was completed on the returned generator.The electrical tests performed in the pa lab found that the generator was at an neos = yes condition.The battery voltage was measured at 2.321 volts, and the memory locations on the generator indicated that 109.122% of the battery had been consumed.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant.Review of the ram/flash data downloaded from the pulse generator shows an indication of post explant increased impedance; the ¿diagvinitialprechange¿ value of 1916 ohms, the ¿diagvinitialpostchange¿ value of 13297 ohms, and the time of change detection 01/11/2022 (explant date ((b)(6)2022).Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist, and the near-end-of-service (neos) condition is an expected event.Other than the noted event (pulsedisabled ¿vboost¿ compliance voltage), there were no additional performance, or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
B5 describe event or problem, corrected data: supplemental report #02 report inadvertently left out relevant information h3 device evaluated by mfr?, corrected data: supplemental report #02 report inadvertently marked 'no' instead of 'yes' h6 adverse event problem codes, corrected data: supplemental report #02 report inadvertently left blank.
 
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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
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key13118347
MDR Text Key282967358
Report Number1644487-2021-01849
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 05/04/2022
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 Date06/10/2017
Device Model Number106
Device Lot Number4397
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 12/10/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/10/2022
03/16/2022
05/04/2022
Supplement Dates FDA Received02/04/2022
04/08/2022
05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient SexFemale
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