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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 08/02/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before. He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated. The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place. The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much. Surgery to secure the generator occurred. The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm. The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched. Additional relevant information has not been received to-date.

 
Event Description

The patient then later provided that before the repositioning surgery it felt like she was being strangled over 2-3 minutes apart and she was in excruciating pain. The patient repeated that she was in pain from the generator migration and that when trying to use her arm the generator would turn over 180 degrees.

 
Event Description

Follow-up from the patient was received providing that he says she had her device adjusted about a year ago and stated the physician had to turn it down because it was too high, and increased her seizure medications.

 
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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 Key6960601
Report Number1644487-2017-04644
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/06/2018
Device MODEL Number103
Device LOT Number5080
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/02/2016
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: 10/18/2017 Patient Sequence Number: 1
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