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); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The reported event cannot be analyzed via laboratory testing.The therapy date(s) for the following device(s) are unknown: model: 3799, scs ipg, model: 3186, scs leads (x2).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.

Event Description

Device 1 of 2: reference mfr.Report: 1627487-2017-03291.It was reported the patient ((b)(6)) experienced pain and swelling at the anchor sites.X-ray and ct images did not reveal any anomalies.In turn, the patient underwent surgical intervention to explant and replace the entire system.There were no alleged deficiencies associated with the implanted leads and ipg.

Event Description

Device 1 of 4.Reference mfr.Report: 1627487-2017-03291.Reference mfr.Report: 1627487-2017-04456.Reference mfr.Report: 1627487-2017-04470.Further investigation identified there were no issues noted post-operative in regards to pain at the anchor sites.In addition, it was reported the patient's leads had dislodged during the surgery and as a result, the leads were replaced.The ipg was electively replaced to take advantage of new technology.Note: the leads are being included as device 3 and device 4.

• 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: 6666194
• MDR Text Key: 78348160
• Report Number: 1627487-2017-03290
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 1192
• Device Lot Number: 4665408
• Other Device ID Number: 05414734400671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• 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