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 Bacterial Infection (1735)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Date of event and therapy dates are estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 1627487-2021-14612, 1627487-2021-14613, 1627487-2021-14614.It was reported that the patient had developed an infection at the anchor site, and cultures taken revealed trace amounts of (b)(6).As a result, the infection site was opened, washed, and closed on an unknown date (estimated (b)(6) 2021).The patient was treated with oral antibiotics, iv antibiotics, and an i&d, with powdered vancomycin placed in the wound.The patients condition is improving.

Manufacturer Narrative

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.

Manufacturer Narrative

D4 - additional device information, d6a - date of implant, and h4 - device manufacture date were adjusted with correct product information, as incorrect information had been used in previous reporting.(correction).H6 - health effect - impact code: 4645 should have been 4644.(correction).

Event Description

Additional information was received that the infection has cleared.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11938217
• MDR Text Key: 254243405
• Report Number: 1627487-2021-14611
• 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,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7814088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCOR; SCS LEAD (2); SCS ANCOR; SCS LEAD (2)
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 82