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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 Problems High impedance; Detachment of Device or device Component
Event Date 08/14/2018
Event Type  Malfunction  
Event Description

It was reported that the diagnostics at the time of implant were normal. The patient's device was interrogated a month after implant and impedance came back has high. X-rays were conducted an no fractures were visible. The pin was possibly not fully in place however it was difficult to visualize through the x-ray. The patient underwent surgery for a possible revision due to the high impedance upon opening the chest incision it was seen that the lead pin had come out slightly as a consequence of the screw coming undone and the silicone cover was detached. It was reported that the lead pin was inserted properly and secured by tightening the setscrew at the time of initial implant. The surgeon removed the generator and replaced the silicone cover and placed the generator back in. The device was tested and normal impedances were seen. After the surgery, while the patient was recovering, 3 diagnostics tests showed high impedance. And low output current delivered. The patient was taken back in to surgery and it was seen that the lead was again not fully inserted. A new generator was implanted and high impedance was still seen, therefore the lead was revised. The set screw being undone and the detachment of the septum plug is reported. The high impedance suspected to be due to the lead is reported in mfr. Report # 1644487-2018-02262. The explanted generator has not been received to date.

 
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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 Key8242712
Report Number1644487-2019-00063
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5587
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2018
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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