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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Hematoma (1884); Insufficient Information (4580)
Event Date 03/23/2021
Event Type  Injury  
Event Description
It was reported that the patient saw their neurologist to have their stimulation enabled.After this, the patient stated that she feels like she is being stabbed in the neck with stimulation and would like the device disabled.The sales representative was at the clinic visit in which the device was enabled and patient reported to have been able to tolerate the stimulation at that time.Additional information was later received from the patient noting that they had extreme painful stimulation and were having the device explanted due to this.The patient reported suffering from a hematoma post-implant and believed this was the cause of the pain.The patient also posted via social media that the device nearly killed her however it is unclear what adverse event she had in reference to this comment.The explanted product has not been received to date.No additional relevant information has been received to date.
 
Event Description
Explant product has been received for analysis.
 
Event Description
Product analysis (pa) for the returned generator was completed.The proper functionality of the device to deliver the programmed output current was verified in the pa lab.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.The battery, 2.950 volts as measured during completion of the final electrical test, shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 1.883% of the battery had been consumed.There were no performance, or any other type of adverse condition found with the pulse generator.Pa worksheet was reviewed and no anomalies were found.
 
Manufacturer Narrative
G3: date received by manufacturer: inadvertently did not mark the date as 5/13/2021 in the supplemental #01 submitted.H2: if follow-up, what type? inadvertently did not mark correction and instead marked additional information in supplemental #01 submitted.
 
Event Description
Product analysis for the lead was completed.The lead assembly was returned for analysis due to the reported painful stimulation which is outside the scope of analysis.The connector pin has adhesive on the exposed surface at 0.020inches from the small boot o-ring.Other than the above mentioned cosmetic observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Pa worksheet was reviewed and no other anomalies were found.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11724306
MDR Text Key247266169
Report Number1644487-2021-00562
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/09/2021
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 Date06/21/2021
Device Model Number106
Device Lot Number205315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Event Location Other
Initial Date Manufacturer Received 04/01/2021
Initial Date FDA Received04/26/2021
Supplement Dates Manufacturer Received04/19/2021
06/10/2021
06/14/2021
08/16/2021
Supplement Dates FDA Received05/13/2021
06/10/2021
06/30/2021
09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age48 YR
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