MAUDE Adverse Event Report: Houston Generator Model 103

Model Number	103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hyperemia (1904); Anaphylactoid / Anaphylaxis (2218); Swelling/ Edema (4577)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient's caregiver that after their battery replacement, complications had occurred.The patient returned in for evaluation of the healing wound and everything was tightly closed.It was stated that about a week later, the patient experienced swelling and inflammation that looked like a big blister.The physician stated that they had used a thread instead for absorbable suture.It was stated that the medical team decided intervention would be needed as they stated it might be the thread that is not working.Surgical intervention was completed and the sutures were changed out for traditional sutures.The sutures were removed with minor bleeding, but overall adequate.About a month after the stiches were removed, the incision site showed signs of complication again such as redness, swelling, and pt.Fever.It was noted that no infection was identified via cultures, however the patient's pcr had risen, and now the wound is mildly hyperemic.The patient was prescribed an antibiotic due to this pcr increase and hyperemia.Later, information was received indication that the plan to resolve this issue was to irrigate the surgical site with vancomycin.No additional known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: Generator Model 103
• Common Device Name: Generator
• Manufacturer (Section D): Houston; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): Houston; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics boulevard; suite 600; houston, TX 77058 ; +1(281)667-2681
• MDR Report Key: 50842621
• Report Number: 1644487-2026-11109
• Device Sequence Number: 10039786
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: 103
• Device Lot Number: 8182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male