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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 11/01/2018
Event Type  Injury  
Event Description
It was reported that the patient was implanted with vns to treat depression, and that the patient experienced a cardiac arrest at the end of a surgery in november 2018.Per the reporter, the patient¿s battery has been dead for some amount of years.There was no indication the surgery was associated with vns; however, a concern was expressed that the cardiac arrest may be associated with the lead remaining attached to the vagus nerve.No additional or relevant information has been received to date.
 
Event Description
Further follow up with the anesthesiologist confirmed that the vns device was recently ruled out as a possible contributor to the cardiac event, as it was confirmed to be "non-functional," which was defined as the generator battery being completely depleted.It was further confirmed that the vagus nerve was not manipulated during the procedure, and that the patient has no evidence of cardiac disease.It was mentioned that the patient will have the occasional unifocal pvc and fainting spells attributed to "vasovagal syndrome." additionally, it was noted that the patient does have a history of possible cataplexy but was never medicated for it.No other relevant information has been received to date.
 
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Brand Name
LEAD MODEL 302
Type of Device
LEAD
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 Key8556175
MDR Text Key143271805
Report Number1644487-2019-00802
Device Sequence Number1
Product Code MUZ
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 company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/29/2019
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 Date06/17/2006
Device Model Number302-20
Device Lot Number010763
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age13 YR
Event Location Other
Initial Date Manufacturer Received 04/03/2019
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer Received06/11/2019
Supplement Dates FDA Received06/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2004
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) Required Intervention;
Patient Age51 YR
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