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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The patient reported that they are having inflammation and are unable to turn their neck. The patient¿s neurologist was looking for a surgeon in order to have their device explanted. Clinic notes were received for the patient¿s explant surgery. Per the clinic notes, the patient has neck pain that she believes is due to the lead pulling on their nerve. The pain occurs intermittently and mild head turns can set off severe pain in her neck and in the muscles, and she limits her neck motion and arm motion to avoid pain. The patient¿s device was disabled for about two years. Programming history was reviewed for the generator. The generator normal mode was disabled on (b)(6) 2013, however magnet mode was left on. The patient¿s generator was completely disabled on (b)(6) 2015. No programming anomalies were seen. Information was received from the physician's assistant. It was unknown when the patient¿s pain began, and the patient had x-rays taken that appeared normal. The physician¿s assessment on the pain was unknown. The patient¿s device was disabled prior to her coming to their clinic, and the reason for disablement was unknown. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

 
Event Description

The patient¿s generator and lead were explanted. The explanting facility historically does not return devices, therefore the devices have not been returned. No additional information has been received.

 
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Brand NamePULSE GEN MODEL 105
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 Key8272345
Report Number1644487-2019-00111
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/20/2014
Device MODEL Number105
Device LOT Number3332
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age4 yr
Event Location Other
Date Manufacturer Received02/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2002
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: 01/23/2019 Patient Sequence Number: 1
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