MAUDE Adverse Event Report: ABBOTT MEDICAL SCS CONVENTIONAL IPG; SCS IPG

Model Number NMD0005

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.

Event Description

It was reported that shortly after ipg was replaced in 2023 patient experienced an infection at the ipg site.As a result, surgical intervention was undertaken on an unknown date wherein patients system was explanted to address the issue.Infection has resolved and patient was reimplanted on (b)(6) 2024.

Manufacturer Narrative

Further clarification from field representative indicated that patient only had one scs system.This report was filed in error.

Event Description

Additional information indicates that patient never had ipg swap in 2023, patient was implanted in 2021 and patient was explanted in 2023 for infection reported in related manufacturer reference number: (b)(4).

• Brand Name: SCS CONVENTIONAL 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: 18902568
• MDR Text Key: 337642110
• Report Number: 1627487-2024-07543
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NMD0005
• 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
• 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 ANCHOR (X2); SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Male