MAUDE Adverse Event Report: ABBOTT MEDICAL ORION RC SCS IPG

Model Number 32400

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that the patient was experiencing constant burning at the ipg site, whether therapy was on or off or the ipg was charging or not.As a result, the patient may undergo surgical intervention to address the issue.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be 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: 18943629
• MDR Text Key: 338154595
• Report Number: 1627487-2024-07647
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067040763
• UDI-Public: 05415067040763
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 10146859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 104 KG