MAUDE Adverse Event Report: HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number	103
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2011
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up #3 (submitted 08/10/2011), follow up #4 (submitted 08/19/2011) and follow up #5 (10/26/2011) were submitted under the incorrect manufacturing report number of 1644487-2011-01531.The manufacturing report number for follow up #3, follow up #4 and follow up #5 should have been manufacturing report number 1644487-2011-00585.Follow up #3 would be the next follow up report under the correct manufacturing number, however it was unable to be submitted under the correct manufacturing report number due to errors received.Due to the age of the previous reports, it was recommended by the cdrh help desk to categorize this correction report submission as an initial report to avoid the errors.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.
Event or Problem Description
During a review for an fda request, it was discovered that a correction report is needed for a report previous submitted under manufacturing number 1644487-2011-00585.Follow up #3 (submitted 08/10/2011), follow up #4 (submitted 08/19/2011) and follow up #5 (10/26/2011) were submitted under the incorrect manufacturing report number of 1644487-2011-01531.The manufacturing report number for follow up #3, follow up #4 and follow up #5 should have been manufacturing report number 1644487-2011-00585.Follow up #3 would be the next follow up report under the correct manufacturing number, however it was unable to be submitted under the correct manufacturing report number due to errors received.Due to the age of the previous reports, it was recommended by the cdrh help desk to categorize this correction report submission as an initial report to avoid the errors.

• Brand Name: PULSE GEN MODEL 103
• Common Device Name: GENERATOR
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 23735347
• Report Number: 1644487-2025-10927
• Device Sequence Number: 21473363
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/19/2011
• Device Model Number: 103
• Device Lot Number: 201025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Female