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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Mechanical Problem (1384)
Patient Problem Seizures (2063)
Event Date 11/19/2020
Event Type  malfunction  
Event Description
It was reported that low output current message was seen on a m1000 generator.Two weeks prior, the patient lost perception of stimulation and his seizures returned (implying increased seizures).The patient couldn't even feel her magnet swipes when her magnet output current was programmed to much higher than typical.The doctor reported that they were having major issues communicating with the generator.Impedance values and battery status was okay.Follow-up found that error code 254 was observed while interrogating the device.This error code is typically related to the generator's reed-switch being stuck closed.When the reed switch is stuck closed, the patient will not receive stimulation from the generator.Data review of the internal generator data confirmed that the vns reed switch was closed since mid-november and would not be providing stimulation.The manufacturer's device history records of the m1000 generator were reviewed.The generator passed final functional and quality specifications prior to release.No known surgical intervention has occurred to date.No further relevant information has been received to date.
 
Event Description
It was reported that they tried swiping the magnet over the generator site and tried resetting the generator and it didn't resolve the problem.No known surgical intervention has occurred to date.No further relevant information has been received to date.
 
Event Description
The patient's generator was replaced due to the reed switch malfunction.The suspect product has not been received for analysis to date.No further relevant information has been received to date.
 
Event Description
The suspect generator was received for analysis but analysis has not been completed to date.No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the returned generator.Reed switch failure was verified.As received the generator was able to be communicated with and diagnostics were ran and found to be within normal limits.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.The generator showed signs of variation in the output and magnet signals after the magnet was applied to the pulse generator.The magnet was applied to the pulse generator for approximately 25-minutes and then removed from the pulse generator.After the magnet was removed from the pulse generator the outputs (output or magnet) did not resume, indicating a closed reed switch.Prior to the magnet being applied to the pulse generator, the output signals demonstrated the expected level of output and magnet currents.The generator performed according to functional specifications except for the magnet detection specification.The reed switch was removed from the generator and underwent a functional test and performed according to specifications.However , after a magnet was applied to the reed switch, the reed switch failed functional specifications and the reed switch was determined stuck closed.No further relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11092714
MDR Text Key224397798
Report Number1644487-2020-01749
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,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/14/2021
Device Model Number1000
Device Lot Number204921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Event Location Other
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received12/30/2020
01/22/2021
03/24/2021
05/18/2021
Supplement Dates FDA Received01/21/2021
02/16/2021
04/16/2021
06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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