MAUDE Adverse Event Report: ABBOTT MEDICAL ORION RC SCS IPG

Model Number 32400

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/09/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patients lead had disconnected from the ipg.Issue was confirmed vi x-ray imaging.Surgical intervention may be taken at a later date to address the issue.

Manufacturer Narrative

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.

Event Description

Additional information received indicates that surgical intervention was undertaken on (b)(6) 2024, wherein the lead was explanted.

• 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: 19041182
• MDR Text Key: 339433876
• Report Number: 1627487-2024-07930
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067040763
• UDI-Public: (01)05415067040763(10)10129752(17)251214
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 32400
• Device Lot Number: 10129752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2023
• 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; SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 102 KG