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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
Event Date 03/21/2016
Event Type  Malfunction  
Event Description

It was reported that patient's device was showing eos yes after only being implanted for two years. The patient¿s settings were still at 0ma due to the eos pulse disablement. A review of device history records for the generator shows that no unresolved non-conformances were found. Internal investigation determined that this behavior was likely related to an increased duration of the high battery impedance experienced by batteries during the beginning of life (bol) or an internal short that managed to ¿burn¿ itself out.

 
Event Description

The reported allegations of ¿premature end of life (eol)¿, ¿device failure¿, and ¿no stimulation¿ were duplicated in the lab. During the bench interrogation, the pulse generator interrogated at a distance of 0. 0 inches between the pulse generator and the programming wand, the pulsedisabled and eos warnings were set. A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba. The battery was removed. The pcba was subjected to a postburn electrical test. Results show that the pcba failed several electrical tests: supply current 2ma/normal, supply current off, supply current off sense, and trim diagoncurrent. Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba. After the trimmed edge of the pcba was cleaned, a postburn electrical test was performed again and the pcba passed the previously failed tests. Based on these 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 allegations.

 
Event Description

Review of the programming data confirmed that the device was depleting prematurely. 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. Patient underwent generator replacement surgery. The explanted generator has not been received to date. Patient mentioned that vns therapy worked really well for her prior to the battery reaching eos. She was even seizure free for about 9 months, and then she had one seizure when the device reached eos.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7920766
Report Number1644487-2018-01725
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/28/2017
Device MODEL Number106
Device LOT Number203833
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/21/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/28/2018 Patient Sequence Number: 1
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