MAUDE Adverse Event Report: ORTHOFIX PEMF - CERVICAL STIM; BONE GROWTH STIMULATOR

Model Number	655505-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Loss of consciousness (2418)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported he was developing bradycardic heart rhythm and experienced loss of consciousness.Patient stated he has no history of such symptoms.Patient seeked treatment for bradycardic heart rhythm and has had a 3 vessel bypass.
Additional Manufacturer Narrative
The device was not returned for evaluation as the patient resumed use after being treated for cardiac symptoms by cardiologist.It cannot be determined if the loss of consciousness was device related.No additional information was provided.

• Brand Name: PEMF - CERVICAL STIM
• Common Device Name: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 23835003
• Report Number: 2183449-2025-00039
• Device Sequence Number: 4993034
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: Lay User/Patient
• Device Model Number: 655505-0001
• Device Catalogue Number: 5505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male