MAUDE Adverse Event Report: ABBOTT MEDICAL SCS EXTENSION; DRG LEAD EXTENSION

Model Number MN20550-50

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2023-05975.It was reported that the patient was experiencing loss of therapy and tingling around the ipg site at high amplitudes.X-ray revealed that the drg lead had migrated and the drg lead extension was broken.As a result, the patient may undergo surgical intervention to address the issue.

Manufacturer Narrative

Date of event is estimated.Date of implant is unknown.Initial reporter phone number: (b)(6).

Manufacturer Narrative

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 incident could not be conclusively determined.

• Brand Name: SCS EXTENSION
• Type of Device: DRG LEAD EXTENSION
• 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: 18358598
• MDR Text Key: 330904877
• Report Number: 1627487-2023-05974
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: MN20550-50
• Device Lot Number: AB2313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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
• Patient Outcome(s): Other