MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discharge (2225); Post Operative Wound Infection (2446)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 4 of 4.Reference mfr.Report: 1627487-2018-09352.Reference mfr.Report: 1627487-2018-09353.Reference mfr.Report: 1627487-2018-09354.It was reported (canada) the patient presented to the emergency room (er) due to increased pain, drainage and swelling at the lead site(s).The incision sites were cleaned and the patient was sent home with antibiotics.The patient returned to the er a few days later with continued symptoms and discharge at the anchor site.In addition, the patient experienced night sweats and chills.The entire system was explanted on (b)(6) 2018.

Event Description

Device 4 of 4: reference mfr.Report: 1627487-2018-09352 , reference mfr.Report: 1627487-2018-09353 , reference mfr.Report: 1627487-2018-09354.Follow-up identified the patient's infection was confirmed via cultures.

Event Description

Device 4 of 4: reference mfr.Report: 1627487-2018-09352, reference mfr.Report: 1627487-2018-09353 , reference mfr.Report: 1627487-2018-09354.Follow-up identified the infection has resolved after administration of antibiotics.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: palka sharma ; 6901 preston road; plano, TX 75024 ; 9725264823
• MDR Report Key: 7920629
• MDR Text Key: 122148047
• Report Number: 1627487-2018-09355
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Model Number: 1192
• Device Lot Number: 6210777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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
• Patient Outcome(s): Other
• Patient Weight: 70