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

Model Number 1192

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

Patient Problems Fever (1858); Pain (1994); Swelling/ Edema (4577)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

Related manufacturer report numbers: 3006705815-2021-00350, 3006705815-2021-00557, 3006705815-2021-00558, 1627487-2021-01176.It was reported the patient was experiencing pain and swelling at the ipg site that radiated to the opposite side of the back.Patient also reported a fever with sweats.The physician stated the patient had cellulitis at the ipg and lead incision sites.As a result, the patient underwent surgical intervention during which the system was explanted with no complications.

Manufacturer Narrative

Correction: section h6 health effect - clinical code should have included 1858 and 1994 in the initial report.This correction is reflected in this additional report 1.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS LEAD ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11309211
• MDR Text Key: 231207064
• Report Number: 1627487-2021-01174
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: 07/23/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7579597
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG; SCS LEAD (X2); SCS LEAD ANCHOR; SCS IPG; SCS LEAD (X2); SCS LEAD ANCHOR
• Patient Outcome(s): Other
• Patient Weight: 68