MAUDE Adverse Event Report: ABBOTT MEDICAL ORION RC SCS IPG

Model Number 32400

Device Problem Temperature Problem (3022)

Patient Problems Failure of Implant (1924); Burning Sensation (2146)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.

Event Description

It was reported that the patient was experiencing a heating sensation when charging their ipg.The patient noted a burning smell and that their ipg site was warm to the touch.No visible burn or redness was present at the ipg site.Next course of action is undetermined at this time.

Manufacturer Narrative

A patient experienced a heating sensation when charging their ipg was reported to abbott.The patient noted a burning smell and that their ipg site was warm to the touch.No visible burn or redness was present at the ipg site.Abbott sent a charger replacement and issue was resolved.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: ORION RC SCS IPG
• Type of Device: SCS IPG
• 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: 18822789
• MDR Text Key: 336732673
• Report Number: 1627487-2024-07311
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 32400
• Device Lot Number: 9199502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS LEAD (X2).; SCS LEAD ANCHOR(X2).
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 77 KG