MAUDE Adverse Event Report: ABBOTT MEDICAL SCS EXTENSION

Model Number NMD0003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.The unique device identifier (udi) number is unknown because the lot number was not provided.The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number 1627487-2021-13113.Related manufacturer reference number 1627487-2021-13114.Related manufacturer reference number 1627487-2021-13118.It was reported that patient experienced infection at lead and extension sites.Reportedly, the devices were pushing through the skin.As a result, surgical intervention was undertaken wherein the entire system was explanted and replaced to address the issue.

• Brand Name: SCS EXTENSION
• Type of Device: SCS 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 11697325
• MDR Text Key: 246436297
• Report Number: 1627487-2021-13117
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NMD0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 93