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 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event and therapy date are estimated.

Event Description

Related manufacturer reference number: 3006705815-2020-33012.Related manufacturer reference number: 3006705815-2020-33013.Related manufacturer reference number: 3006705815-2020-33014.Related manufacturer reference number: 1627487-2020-48443.It was reported that the patient was diagnosed with infection at the ipg site which later progressed to the leads.As such, the entire system was explanted to address the issue.The infection is being treated with oral antibiotics.

Manufacturer Narrative

Per the additional information received, there is no allegation against this device.Hence, this does not meet the reportability criteria.

Event Description

Additional information received indicates that the patient experienced infection only at the ipg pocket site.Reportedly, the infection has resolved.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10952391
• MDR Text Key: 219878930
• Report Number: 1627487-2020-48442
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7575564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR MODEL 1192; SCS IPG MODEL 3660; SCS LEAD MODEL 3186 (X2)
• Patient Outcome(s): Other