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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 11/03/2020
Event Type  Injury  
Event Description
It was reported through a clinical study that a patient experienced and recovered from cardiorespiratory arrest.The event was noted as not related to the implant procedure but possibly related to vns stimulation.Start date was (b)(6) 2020 and date of first stimulation was (b)(6) 2020.The patient was implanted (b)(6) 2020.Medical intervention to preclude a serious injury was taken.The patient was admitted to the hospital (b)(6) 2020 to (b)(6) 2020.The patient's vns treatment was interrupted as a result of this event.Information was received from the physician and clinic notes regarding the patient's reported cardiopulmonary arrest.It was reported that the patient's vns was implanted and turned on.There were no cardiovascular abnormalities during the procedure.Later that day (approximately 7 hours later), the patient presented with oxygen desaturation of 88% and bradycardia.The bradycardia progressed to until disappearance of valid peripheral pulse/ cardiac arrest and further desaturation to 20% oxygen saturation.3 cycles of cpr were required to resuscitate the patient.Anesthesiologic evaluation was performed without indication for intensive care admission and the vns was switched off.3 days later, the vns was switched on to the same output current as before and then turned back off with the holter monitor findings normal while vns stimulation was on and off.3 days later he vns was switched on again without clinical problems.The patient was then discharged from the hospital with the vns on.The doctor believed that the cardiac arrest may be related to the vns stimulation due to the temporal correlation of the event with vns implantation and activation.However, he also believed it was probably related to the patients' clinical condition based on the patient having previous desaturation events (caused by crying or due to seizures).Of note the patient had a similar episode at (b)(6) months old (and the patient is now (b)(6) years old.) the manufacturer's device history records of the patient's m1000 were reviewed and the generator passed final functional and quality specifications prior to release.No device malfunction was reported.No further relevant information has been received to date.
 
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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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key10992220
MDR Text Key220940945
Report Number1644487-2020-01659
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/11/2020
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 Date08/20/2021
Device Model Number1000
Device Lot Number6443
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 11/16/2020
Initial Date FDA Received12/11/2020
Date Device Manufactured10/21/2019
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 Outcome(s) Hospitalization; Required Intervention;
Patient Age3 YR
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