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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2018
Event Type  malfunction  
Event Description
A patient's device was explanted for an unknown reason.It was indicated from the return product form that the replacement was prophylactic.Analysis was completed for the returned generator.The device was confirmed to be at eos, which was expected due to the generator remaining "on" post-explant.Review of the data downloaded from the generator showed a high impedance.Programming history showed ok diagnostics prior to the noted high impedance.No additional, relevant information was received to date.
 
Event Description
Further follow up with the patient's nurse confirmed that the patient's device was truly explanted for prophylactic replacement on (b)(6) 2017, which means that the high impedance registered on the data download from the generator occurred after explant and is most likely related to the explant procedure.Additionally, it was confirmed that device diagnostics were performed just prior to the surgery and confirmed that all diagnostics were within normal limits.No other relevant information has been received to date.
 
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Brand Name
LEAD MODEL 302
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8547777
MDR Text Key143587320
Report Number1644487-2019-00772
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 company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/04/2019
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 Date11/24/2005
Device Model Number302-20
Device Lot Number009637
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 04/04/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received07/22/2019
Supplement Dates FDA Received08/04/2019
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
Patient Age50 YR
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