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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 False Alarm (1013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2018
Event Type  malfunction  
Event Description
During a periodic programming history database review, high lead impedance was observed upon performing a system diagnostics.The impedance has been within normal limits ever since.Device history record review for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators.As indicated in the physician's manual, high lead impedance (5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction.No other relevant information has been received to date.
 
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 "efects or malfunctions.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
 
Event Description
The patient underwent a generator replacement surgery.The explanted generator was not made available for return.
 
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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 Key17755956
MDR Text Key324124284
Report Number1644487-2023-01325
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
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 Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/14/2024
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 Date07/08/2020
Device Model Number1000
Device Lot Number204555
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 08/23/2023
Initial Date FDA Received09/15/2023
Supplement Dates Manufacturer Received02/19/2024
Supplement Dates FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2018
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 Age58 YR
Patient SexMale
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