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 Discomfort (2330)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reference manufacturer number: 1627487-2020-47972.It was reported that the patient developed discomfort at the anchor site after losing 50 pounds.In turn, the patient underwent surgical intervention wherein the scs anchors were explanted and replaced to address the issues.Note: since it is not known which device contributed to the issue, all possible devices are being reported on.

Manufacturer Narrative

It was reported to abbott that the patient was experiencing pain at the anchor site.The report stated that the patient's anchors and ipg were replaced on (b)(6) 2020 due to pain at the anchor site.Therapy was restored at post op.All information pertaining to this event has been reviewed and no further action is required at this time.Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10864113
• MDR Text Key: 217085408
• Report Number: 1627487-2020-47971
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067016621
• UDI-Public: 05415067016621
• 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: 11/30/2020

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: 04/30/2017
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 5076284
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 1192, SCS ANCHOR
• Patient Outcome(s): Other
• Patient Weight: 64