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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 Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/02/2023
Event Type  Injury  
Event Description
It was reported that immediately after the patient was implanted they had worsening voice alteration, increased difficulty swallowing, chills and shortness of breath and went to the emergency room.The patient was later hospitalized that same day due to a diagnosis of pneumonia.Additionally it was noted that the patient suffered from a vagal nerve injury that as resulted in vocal cord paralysis.No other relevant information has been received to date.
 
Manufacturer Narrative
F10 health effect, clinical code: code e2402 utilized; appropriate term ¿voice alteration¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿chills¿ is not available.Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.Health effect - clinical code :e012202; health effect - clinical code :e2402; health effect - clinical code :e0733.
 
Event Description
Additional information was received reporting bilateral hearing loss and tissue damage from surgery no other relevant information has been received to date.
 
Manufacturer Narrative
A2 age at the time of event, corrected data - the initial reporter inadvertently used the wrong age for the patient.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿tissue damage¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿bilateral hearing loss¿ is not available.F10 health effect, clinical code, corrected data: the initial reporter inadvertently used e2402 for & voice alteration which was already captured in an existing code already used and did not need to be used.
 
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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
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key18252316
MDR Text Key329556253
Report Number1644487-2023-01673
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 Other,Consumer
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2024
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 Model Number1000
Device Lot Number206003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 11/06/2023
Initial Date FDA Received12/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2023
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; Disability; Required Intervention;
Patient Age45 YR
Patient SexFemale
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