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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 Detachment of Device or device Component
Event Date 03/20/2019
Event Type  Malfunction  
Event Description

Initial report was that the generator's septum plug came out of the generator during lead pin insertion during surgery. The surgeon attempted to replace the septum plug and it was noted that the septum plug would not seat properly in the generator. The lead insertion was noted to be without difficulties. A backup generator was used in place. The device history records for the generator were reviewed and show that no unresolved non-conformance's were found. The device met all specifications for release prior to distribution. The product was received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

 
Event Description

Further information was received clarifying the timeline of the septum plug becoming detached. The patient was opened and the generator was exposed in the patient in preparation for generator removal. The surgeon then requested a new generator be opened which was done and the hex screwdriver was handed to the surgeon. The surgeon removed the implanted generator and connected the replacement generator. It was noted during this attempt to implant the replacement generator that the septum plug came out and was removed from the sterile field. It was noted that this occurred within less than 60 seconds. It was noted that at no point during the process a cautery instrument was present. The operation room support specialist present at the surgery confirmed that she observed the detached septum plug and noted that when the surgeon was unable to re-set the plug it was determined that the patient should be implanted with a different generator. Further information was received confirming that no electrocautery was used in the sterile field or around the surgery table. It was unknown if electrocautery was used outside of the sterile field or away from the surgery table. It was confirmed that 3 clicks were heard when the setscrew was placed in the header of the replacement generator. No other relevant information has been received to date.

 
Event Description

Generator product analysis was completed. The product analysis lab did not observe detachment of the septum plug. The septum plug and pulse generator header septum cavity meet specification requirements. Visual examination, performed at the product analysis test bench, showed scratches on the pulse generator case and header. These scratches are most likely associated with manipulation of the device during the implant/explant procedure as the observed markings are consistent with devices typically used in a surgical procedure. The septum shows to be cored, melted (next to the core, possibly from an electro-cautery tool) and damaged on the underneath side from the extraction of the setscrew. The setscrew shows mechanical damage to the setscrew socket, septum debris in the setscrew socket, and burn marks. There were no performance of any other type of adverse events found with the pulse generator.

 
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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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8506083
Report Number1644487-2019-00698
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number106
Device LOT Number204670
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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