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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL UNKNOWN

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LIVANOVA USA, INC. LEAD MODEL UNKNOWN Back to Search Results
Device Problems High impedance (1291); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2022
Event Type  malfunction  
Event Description
During device evaluation of returned generator, high impedance was observed.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 "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
 
Event Description
This generator was received in a shipment of generators on 03/01/2023 and was confirmed on (b)(6) 2023 to be returned due to a standard generator replacement per the (b)(6) hospital.This hospital has historically and currently reports any complaints or troubleshooting issues to livanova directly.Therefore if this generator was related to a true high impedance while implanted in a patient, they would have reported to us at that time they were aware.Due to privacy laws, the united kingdom cannot send implant or explant dates of the generators unless there is an active complaint alleged.Upon return this generator it showed high impedance in data history during product analysis.This will not be captured as a high impedance device malfunction as this is an expected function of the generator to record any impedance change of >25% which occurs both before implant and after explant due to not having lead connected while implanted in patient.Due to this and the information regarding all of these generators that were returned from this facility indicated to be explanted due to normal replacement, this high impedance is not indicative of a true malfunction and therefore will not be captured.
 
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Brand Name
LEAD MODEL UNKNOWN
Type of Device
LEAD
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 Key18793403
MDR Text Key336433156
Report Number1644487-2024-00214
Device Sequence Number1
Product Code LYJ
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 Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/22/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/27/2024
Supplement Dates Manufacturer Received03/05/2024
Supplement Dates FDA Received03/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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