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

Model Number	1192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Device 4 of 4.Reference mfr.Report: 1627487-2018-09360, reference mfr.Report: 1627487-2018-09361, reference mfr.Report: 1627487-2018-09438.It was reported the patient developed an infection at the lead site.The patient is currently at the hospital for unrelated health issues.
Event or Problem Description
Device 4 of 4 : reference mfr.Report: 1627487-2018-09360 , reference mfr.Report: 1627487-2018-09361 , reference mfr.Report: 1627487-2018-09438.Follow-up identified the physician 'classified' the infection as a bed/pressure sore.The physician performed an x-ray and concluded the lead/system is not causing the reported soreness.The plan is to refer the patient to a wound care specialist.

• Brand Name: SWIFT-LOCK ANCHOR
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7924289
• Report Number: 1627487-2018-09439
• Device Sequence Number: 1653542
• Product Code: GZB
• UDI-Device Identifier: 05415067016621
• UDI-Public: 05415067016621
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 1192
• Device Lot Number: 5049148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other