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 Unspecified Infection (1930)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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 reference numbers: 3006705815-2021-03899, 3006705815-2021-03900, 1627487-2021-16207.It was reported that patient was diagnosed with infection at the lead site.As a result, surgical intervention occurred to explant the leads and anchors and patient was prescribed antibiotics.The infection resolved.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12299008
• MDR Text Key: 265772353
• Report Number: 1627487-2021-16208
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2021

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: 09/10/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7162508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X2); SCS ANCHOR
• Patient Outcome(s): Other
• Patient Weight: 95