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 Problem Pain (1994)

Event Date 02/24/2020

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

Related manufacturer reference number: 1627487-2020-02803, 1627487-2020-02804, 3006705815-2020-01208.It was reported the patient experienced pain at the anchor sites.Surgical intervention took place on (b)(6) 2020 wherein the anchors were explanted and replaced, and the leads were repositioned due to them moving during the replacement of the anchors.

Manufacturer Narrative

No implanted devices were returned for evaluation.The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.

Event Description

Additional information received indicates the pain has resolved.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9841948
• MDR Text Key: 183752747
• Report Number: 1627487-2020-02802
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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: 04/30/2018
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 5514919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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: MODEL 1192 ANCHOR; MODEL 3186 X 2 LEAD
• Patient Outcome(s): Other
• Patient Weight: 57