MAUDE Adverse Event Report: ABBOTT MEDICAL ORION RC CHARGING CABLE AND AC ADAPTER

Model Number	16740
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that when attempting to charge charger, patients charging cable and a port on patient's charger melted.Patient experienced no harm.Product was replaced to address the issue.
Additional Manufacturer Narrative
The event of charger damaged/burned was reported to abbott.Patient reported they looked at the charger and saw that the charger cord was melted/burned, and the charger port was melted.Issue resolved with a replacement charger and cord.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: ORION RC CHARGING CABLE AND AC ADAPTER
• Common Device Name: CHARGING CABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21288921
• Report Number: 1627487-2025-00491
• Device Sequence Number: 15444195
• Product Code: LGW
• UDI-Device Identifier: 05415067040756
• UDI-Public: (01)05415067040756(10)8147794
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: Health Professional
• Device Model Number: 16740
• Device Catalogue Number: 16740
• Device Lot Number: 8147794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCS ANCHOR (X2); SCS IPG; SCS LEAD (X2)
• Patient Sex: Female
• Patient Weight: 57 KG