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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Convulsion, Clonic (2222)
Event Date 04/12/2023
Event Type  malfunction  
Event Description
It was reported that the patient experienced an electric shock from a welding machine and has had increased seizures ever since.The patient was seen by their physician who discovered the shock had defaulted the generator back to original settings.The physician programmed patient back to desired settings and the device is functioning fine with no damage from the shock.No other relevant information has been received to date.
 
Manufacturer Narrative
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.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key16895328
MDR Text Key314827043
Report Number1644487-2023-00572
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 Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000
Device Lot Number205902
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 04/14/2023
Initial Date FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2022
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 Age43 YR
Patient SexMale
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