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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 Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury  
Event Description

It was reported that a patient was to be referred for replacement surgery as the patient has had 3 seizures in the last month. No surgery has occurred to date. No further relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem. Corrected data. Initial mdr inadvertently missed including the programming history review.

 
Event Description

Programming history was reviewed for the device. Diagnostic information was available showing that the battery was functioning as intended, with ok battery status and ok impedance. Follow-up information was received from the physician stating that seizure levels were above pre-vns baseline levels and that the suspected cause of the increase in seizures was due to a need for a battery change, although it was not clear if this was due to a suspected malfunction or low battery. Settings and diagnostics were provided, showing the same information observed through review of the programming history database. No surgery has occurred to date. No further relevant information has been received to date.

 
Event Description

A battery life calculation was performed with the programming data available to the manufacturers. The results of the calculation indicated that it was unlikely that the device was nearing end of service; therefore, battery depletion was likely not the cause of the increased seizures. No additional relevant information was received to date.

 
Event Description

The patient underwent a successful prophylactic generator replacement. It was noted that the hospital discards all explanted devices so no explanted device is expected for return for analysis. No further additional information has been 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7651118
Report Number1644487-2018-01104
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number103
Device LOT Number201943
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2011
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: 06/29/2018 Patient Sequence Number: 1
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