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 Hypersensitivity/Allergic reaction (1907)

Event Date 11/17/2020

Event Type  Injury  

Event Description

Manufacturer report reference numbers: 3006705815-2021-00683, 1627487-2021-01378.It was reported that the patient experienced an allergic reaction since the system was implanted.An allergy test was taken and it revealed that the patient was allergic to stainless steel and silicon.As a result, the patient may undergo surgical intervention to address the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11343891
• MDR Text Key: 232394720
• Report Number: 1627487-2021-01377
• 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: 02/19/2021

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: 02/11/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7372900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 1192, SCS ANCHOR; MODEL 3660, SCS IPG; MODEL 1192, SCS ANCHOR; MODEL 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 84