MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 90 CM; SCS LEAD

Model Number 3169

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

Patient Problem Unspecified Infection (1930)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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 1627487-2021-16281.Related manufacturer reference number 1627487-2021-16283.It was reported that patient experienced infection at lead site.Patient was treated with antibiotics and underwent surgical intervention wherein the entire was explanted to address the issue.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 90 CM
• Type of Device: SCS LEAD
• 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: 12315952
• MDR Text Key: 266302194
• Report Number: 1627487-2021-16287
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406116
• UDI-Public: 05414734406116
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: 3169
• Device Catalogue Number: 3169
• Device Lot Number: 6320330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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 LEADS X2
• Patient Outcome(s): Other
• Patient Weight: 84