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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 06/05/2019
Event Type  malfunction  
Event Description
Initial report was that a physician was inquiring about whether or not the patient¿s device had prematurely depleted.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected.Clinic notes were received for the patient.Clinic notes indicated that the vns battery had dropped significantly since the patient¿s last office visit.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
Event Description
Patient underwent generator replacement surgery.The explanted generator was received by product analysis.Product analysis has not been completed to date.
 
Manufacturer Narrative
Corrected data, report no.1: device returned date inadvertently not included.
 
Event Description
Generator product analysis was completed.A visual assessment on the pcba, performed at the product analysis test bench, showed contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.The product analysis lab confirmed an ifi (intensified follow-up indicator)=no condition.Based on 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 Key8744926
MDR Text Key149529133
Report Number1644487-2019-01238
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
Report Date 09/30/2019
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 Date08/05/2017
Device Model Number106
Device Lot Number203469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/05/2019
Initial Date FDA Received06/28/2019
Supplement Dates Manufacturer Received08/07/2019
09/11/2019
Supplement Dates FDA Received08/29/2019
09/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2015
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 Age30 YR
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