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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

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LIVANOVA USA, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 302-20
Device Problems Fracture (1260); High impedance (1291)
Patient Problems Nerve Damage (1979); Paralysis (1997); Paresis (1998); Choking (2464); Cough (4457)
Event Date 12/22/2020
Event Type  malfunction  
Event Description
It was stated that prior to surgery for a routine battery replacement, high impedance was observed.Surgery was performed to revision lead and replace the generator.While explanting existing electrodes, the surgeon noted the left vagus nerve was found to be too attenuated (weakened).Surgeon did not continue with implanting the vns system.The explanted devices were discarded.The patient is set to be reevaluated by the surgeon before being reimplanted.Per the physician, the patient was first observed to have high impedance during check on 12/22/2020.No additional relevant information has been received.
 
Manufacturer Narrative
F10.Health effect - clinical code - codes e2402 were used to house the report of facial flushing and puffy eyes.F10.Component code - correction - code a040101 should have in place of code a072201 in the initial mdr.H6.Investigation findings - correction - code c070603 should have in place of code c0203 in the initial mdr.H6.Investigation conclusions - correction - code d02 should have in place of code d15 in the initial mdr.Health effect - clinical code :e2402.Health effect - clinical code :e2402.
 
Event Description
It was reported the patient was seen in the emergency room on (b)(6) 2021 due to dysphagia, coughing, voice alteration, and facial flushing.Patient was referred to an ent.Per surgical notes, the left vagal nerve was "eroded".Per ent, on the left ipsilateral to the side of the stimulator, there appears to be some time in the vocal cord.The cord appears to be paretic (partial paralysis), but is not full paralyzed.The patient was hospitalized for investigation and ent assessment of the events.Per the neurologist, the dysphagia, coughing and voice alteration are related to the abnormality seen in the nerve.The cause of the facial flushing/puffy eyes was not able to be provided.The event had resolved.No additional relevant information has been received to date.
 
Manufacturer Narrative
B5.Describe event or problem - correction - "there appears to be some tone in the vocal cord" was incorrectly included in supplemental #1 mdr.F6.Health effect - clinical code - correction - code e012204 was inadvertently reported in the supplemental #1 mdr.
 
Event Description
Ent is proposing to fix the patient's vocal cord paresis with a common procedure.Once healed, the plan would be to implant new vns electrodes superior to the original location.Surgeon provided additional information regarding what was observed in surgery.Per the provider, the nerve was thinned out just above the proximal electrode and did not believe the nerve would structurally hold the new electrodes.No additional relevant information has been received.
 
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Brand Name
BIPOL LEAD MODEL 300
Type of Device
LEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key12263544
MDR Text Key264713033
Report Number1644487-2021-01049
Device Sequence Number1
Product Code LYJ
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,foreig
Type of Report Initial,Followup,Followup
Report Date 10/22/2021
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? Yes
Device Operator Lay User/Patient
Device Expiration Date06/30/2018
Device Model Number302-20
Device Lot Number203008
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 07/08/2021
Initial Date FDA Received08/02/2021
Supplement Dates Manufacturer Received08/30/2021
09/28/2021
Supplement Dates FDA Received09/24/2021
10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention; Disability;
Patient Age20 YR
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