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

Model Number	1192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10864113
• Report Number: 1627487-2020-47971
• Device Sequence Number: 2635562
• Product Code: GZB
• UDI-Device Identifier: 05415067016621
• UDI-Public: 05415067016621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K092371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL 1192, SCS ANCHOR
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64