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

Model Number 1192

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

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 3 of 4: reference mfr.Report: 1627487-2018-08849; reference mfr.Report: 1627487-2018-08850; reference mfr.Report: 1627487-2018-08851.It was reported ((b)(6)) the patient experienced ineffective stimulation.Diagnostics indicated high impedance measurements on one lead.Reprogramming was unsuccessful in resolving the issue.X-ray images indicated the leads had migrated.Surgical intervention was undertaken during which the anchor appeared to not hold the lead in place; although it was in a locked position.One lead was explanted and replaced and the other lead was repositioned.In addition, the physician explanted and replaced the anchors.Stimulation was restored following the procedure.

Event Description

Device 3 of 4 :reference mfr.Report: 1627487-2018-08849 , reference mfr.Report: 1627487-2018-08850 , reference mfr.Report: 1627487-2018-08851.

Event Description

Device 3 of 4: reference mfr.Report: 1627487-2018-08849, reference mfr.Report: 1627487-2018-08850 , reference mfr.Report: 1627487-2018-08851.

• 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 ; 9725264823
• MDR Report Key: 7882835
• MDR Text Key: 120472627
• Report Number: 1627487-2018-08851
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Model Number: 1192
• Device Lot Number: 6164566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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