MAUDE Adverse Event Report: ABBOTT MEDICAL ORION RC CHARGER; SCS CHARGER

Model Number	16000
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete case information.
Event or Problem Description
It was reported that the external device charging port melted.There was no reported harm to the patient.The device was replaced to address the issue.
Additional Manufacturer Narrative
The reported observation of charging port melted was confirmed.As received the returned charger port was found melted, however charger was charged and the lab ipg was charged successfully and functioned as intended.The root cause of the observation is unknown.
Additional Manufacturer Narrative
The reported observation of charging port melted was confirmed.As received, the returned charger port was found melted, however, the charger was able to be charged, was able to successfully charge the lab ipg and functioned as intended.The root cause of the observation is unknown.An engineering investigation confirmed the thermal damage was isolated to the charger port interface and not the internal pcb, deducing it was a connector-level failure.The dhr for the charger has been reviewed and there were no issues found.

• Brand Name: ORION RC CHARGER
• Common Device Name: SCS CHARGER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21943218
• Report Number: 1627487-2025-01827
• Device Sequence Number: 8547841
• Product Code: LGW
• UDI-Device Identifier: 05415067040756
• UDI-Public: (01)05415067040756(10)8969551(17)250312
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• 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,Followup
• Report Date (Section B): 05/09/2026

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 Expiration Date: 03/12/2025
• Device Model Number: 16000
• Device Lot Number: 8969551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 04/27/2026
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/25/2025; 05/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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 IPG.; SCS LEAD.
• Patient Sex: Male
• Patient Weight: 68 KG