MAUDE Adverse Event Report: ABBOTT MEDICAL SCS LEAD

Model Number NMD0002

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-00967, related manufacturer reference number: 1627487-2021-00968, related manufacturer reference number: 1627487-2021-00969.This event is being filed to report unspecified scs lead hardware related malfunction.This event was captured within a literature review.

Manufacturer Narrative

A patient's unspecified scs lead hardware related malfunction was reported to abbott.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: SCS LEAD
• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11286906
• MDR Text Key: 230517613
• Report Number: 1627487-2021-00966
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NMD0002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG; SCS LEAD X 2; SCS IPG; SCS LEAD X 2
• Patient Outcome(s): Other