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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 06/11/2008
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported in 2012 that the patient's father called asking for the patient's records from time of implant until when the device was turned off. He believed that the vns almost killed her. Per the father, the patient had aspiration pneumonia and had been admitted to the emergency department. When follow-up was conducted with the physician¿s office in 2012, the physician¿s office stated that the patient had a past history of problems with aspiration even prior to the vns, so they didn¿t believe it was related to the vns or stimulation. The vns was turned off at the family¿s request approximately two months after implant. In 2018, further information from the father was received. He reported that the patient was now in respiratory failure and had had quite a few aspiration and pneumonia events. He stated that the patient hadn¿t had aspiration events prior to the vns. The father believed that one instance of aspiration pneumonia, that had occurred ¿a while ago,¿ had been caused by a feeding tube that he said was needed because the patient couldn¿t swallow due to the vns. Since then, the patient had had multiple instances of aspiration pneumonia due to influenza, which the father did not suspect were related to the vns. Later he indicated that the patient had had multiple aspiration pneumonia events due to the vns. The father reported that the patient had issues with the vns such as throat pain, inability to speak, and inability to swallow food. He said that the patient¿s vns had been disabled permanently between 2012 and 2014 because the patient¿s ent had attributed the dysphagia to the vns. Per the father the ent had looked at the patient¿s throat while the magnet was swiped and the patient¿s throat did not close. Per the father, because the patient¿s throat remained open, fluid and other things could get into lungs, leading to pneumonia. Finally, the father reported that the patient¿s physician had told him that there had never been any problem with the vns. Further follow-up with the physician¿s office found that this father frequently reported this complaint to them and that the patient was recently admitted to the hospital with pneumonia. The physician indicated that he couldn¿t provide an assessment of the events reported by the father until he saw the patient again. No further relevant information has been received, to date.

 
Event Description

It was reported by the patient's father that the patient was permanently damaged and that she had to be on non-stop ventilation due to the vns. He believed that the patient had been too young when she was implanted, and this had caused her problems. Now, he said that the patient was too sick to have the surgery to remove the vns. He believed that the patient would have been better off with seizures. He reported that his daughter was dying. He also wondered if there had been a report of necrotic tissue in the shoulder area/socket--osteonecrosis related to the vns. The physician's office reported that the necrotic tissue in the patient's shoulder had been present for a while. The physician reported that while he, of course, couldn't rule out the vns as a complicating factor in the patient's symptoms, he did not believe that the vns was related to the patient's reported adverse events, including the necrotic tissue. It was reported that the patient had a very complex and severe disease state. The physician reported the father was just trying to make sense of the patient's medical complications. No further relevant 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 Key7497099
Report Number1644487-2018-00747
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 07/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2009
Device MODEL Number103
Device LOT Number1952
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/19/2007
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: 05/08/2018 Patient Sequence Number: 1
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