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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 Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2023
Event Type  malfunction  
Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
 
Event Description
It was reported that error code 34 was seen upon interrogation.Error code 34 is indicative of an unexpected generator reset due to an unknown reason.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.Per the rep, the neurosurgeon in or reportedly had some difficulties with the communication between the tablet and the wand.The error code 34 showed once.She changed new batteries and pressed the power button for more than 10 seconds and cleared the screen.After that everything was fine, and she finished the implantation.The generator worked perfectly.No other relevant information has been received to date.
 
Event Description
Additional information was received reporting that error code 34 did not occur.A review of the data was completed by the quality engineering team.There were also some difficulties with communication between the tablet and the wand.When batteries were changed and power button was pressed for more than 10 seconds, communication re-established and the generator worked well.Decoder data and data logs were reviewed for error code 34.Error code 34 was not seen in the data log file.However, error code 109 was seen which indicates that there was loss of connection for wand.A error message 128 was seen after that which may be due to emi or wand positioning.The communication error was fixed by pressing the power button of the programmer for more than 10 seconds to clear screen and replacing the batteries for wand as recommended by troubleshooting guide.Additionally, with the review of decoder and log files it can be confirmed that there is no issues with generator itself.No other relevant information has been received to date.
 
Manufacturer Narrative
H6: investigation findings: the initial reporter inadvertently left out a relevant code.H6: investigation conclusions: the initial reporter inadvertently used the incorrect code.
 
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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
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key17980993
MDR Text Key326259203
Report Number1644487-2023-01517
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 12/12/2023
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 Model Number1000
Device Lot Number206050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 09/22/2023
Initial Date FDA Received10/20/2023
Supplement Dates Manufacturer Received10/23/2023
12/12/2023
Supplement Dates FDA Received11/17/2023
12/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2023
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 Age40 YR
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