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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Fracture
Event Date 11/08/2018
Event Type  Malfunction  
Event Description

It was reported that a patient's device was showing high impedance. The patient was sent for x-rays of her neck and chest. The device settings were lowered and it was stated that the device was not bothering her after that; so the device was not turned off during the visit. Further updates were received noting additional diagnostics performed on the patient's device. Two diagnostics were performed confirming the high impedance. It was stated that the device was intended to be turned off due to painful stimulation in the neck. The patient had also reported that her neck locks up at times to the left side. After device settings were adjusted, the patient was concerned that fully disabling her device would lead to increased seizures, so the settings were kept at the lower output. The patient reported no longer feeling pain with the new settings. No additional relevant information was received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key8141647
Report Number1644487-2018-02238
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/06/2014
Device MODEL Number103
Device LOT Number3247
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2012
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: 12/07/2018 Patient Sequence Number: 1
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