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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2019
Event Type  malfunction  
Event Description
It was reported that the battery of the patient's vns generator was depleting.The patient's treating medical professional suspected the battery had prematurely depleted.The device history records for the generator were reviewed and show that no unresolved non-conformances were found.The device met all specifications for release prior to distribution and was manufactured with a laser routing process.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Explanted generator was received by product analysis.Product analysis has not been completed to date.
 
Event Description
Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.
 
Event Description
Generator product analysis was completed.The product analysis lab confirmed that the generator was at ifi=no condition.A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba.Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegation of premature end of life.
 
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Brand Name
PULSE GEN MODEL 106
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8495994
MDR Text Key141354759
Report Number1644487-2019-00682
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
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,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 07/08/2019
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 Date07/30/2017
Device Model Number106
Device Lot Number203471
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 03/15/2019
Initial Date FDA Received04/09/2019
Supplement Dates Manufacturer Received05/03/2019
05/30/2019
06/25/2019
Supplement Dates FDA Received05/28/2019
06/20/2019
07/08/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/12/2015
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 Age21 YR
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