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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/23/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4) utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.).
 
Event Description
It is reported that patient had an increase in movement of their generator.The physician had noted that it may require securing the attachment/anchoring the site.The top of the generator is properly secured down however the bottom of the generator is not.This patient has been referred for surgery.No known relevant surgical intervention has occurred to date.No additional or relevant information has been received to date.
 
Event Description
It was reported that the patient was referred surgery.This surgery is noted to be for patient comfort only.No other relevant information has been received to date.No known relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient had underwent a revision surgery of their generator pocket.No device were explanted.The physician states that the reason for the revision surgery was due to patient influence.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key15046973
MDR Text Key296125994
Report Number1644487-2022-00868
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/20/2020
Device Model Number1000
Device Lot Number205519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 06/23/2022
Initial Date FDA Received07/18/2022
Supplement Dates Manufacturer Received07/20/2022
10/25/2022
Supplement Dates FDA Received08/10/2022
11/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age51 YR
Patient SexFemale
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