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 Discomfort (2330)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported the patient experienced discomfort at the anchor site.Subsequently, the patient underwent surgical intervention on (b)(6) 2014, where the patient's anchor was explanted and replaced with a new model.The patient's issue is now resolved.

Manufacturer Narrative

(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer Contact: st. jude medical - neuromodulation; 6901 preston rd; plano, texas 75024
• MDR Report Key: 4366968
• MDR Text Key: 18002020
• Report Number: 1627487-2014-23845
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

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: 04/28/2015
• Device Model Number: 1192
• Device Lot Number: 4040122
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/29/2014
• Date Device Manufactured: 04/18/2013
• 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 3189 (2), SCS LEAD, IMPLANT DATE; MODEL 3788, SCS IPG, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 45 YR