MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

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

Patient Problem Unspecified Infection (1930)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

An event of infection was reported to abbott.The infection has since been resolved.It was conveyed that the infection originates at the lead site(s) and the entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the lead(s).Based on the documents reviewed, the source of the infection remains unknown.Date of event is estimated.Attempts were made to obtain complete event and patient information.Additional information was not provided.

Event Description

Reference manufacturer numbers: 3006705815-2021-03541, 3006705815-2021-03542, 1627487-2021-15764.It was reported that the patient experienced an infection at the scs lead site.In turn, the patient underwent surgical intervention in (b)(6) 2021 wherein the system was explanted.The infection has since resolved.Since it is not known which device contributed to the issue, all possible devices are being reported on.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• 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: 12196465
• MDR Text Key: 262444259
• Report Number: 1627487-2021-15765
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7206105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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: MODEL 1192, SCS ANCHOR; MODEL 3186, SCS LEAD X2
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 68