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 Seroma (2069); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 2 of 4.Reference mfr.Report# 1627487-2017-07824, reference mfr.Report# 1627487-2017-07830, reference mfr.Report# 1627487-2017-07831.It was reported ((b)(4)) the patient experienced discomfort at the anchor site due to possible seroma.Surgical intervention may be taken at a later date to addressed issue.

Event Description

Device 2 of 4, reference mfr.Report# 1627487-2017-07824, reference mfr.Report# 1627487-2017-07830, reference mfr.Report# 1627487-2017-07831.Additional information received identified the patient underwent surgical intervention on (b)(6) 2017 where in the seroma was drained.Also during the surgery the leads were repositioned and the anchors were explanted and replaced.As of (b)(6) 2018 the patient still had some discomfort.

Event Description

Device 2 of 4.Reference mfr.Report# 1627487-2017-07824, reference mfr.Report# 1627487-2017-07830, reference mfr.Report# 1627487-2017-07831.Additional information received identified the issue 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
• MDR Report Key: 7071452
• MDR Text Key: 93353873
• Report Number: 1627487-2017-07825
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 1192
• Device Lot Number: 5851292
• Other Device ID Number: 05414734400671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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
• Treatment: MODEL 3772, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 43 YR