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 Fever (1858); Burning Sensation (2146); Discharge (2225)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 4 of 4.Related manufacturer reference number: 3006705815-2020-31225, related manufacturer reference number: 3006705815-2020-31226, related manufacturer reference number: 1627487-2020-31061.It was reported the patient experienced burning sensation and drainage at the lead incision site, along with a low-grade fever.A ct scan was normal.To address the issue, the physician opted to explant the patient¿s system.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

Event Description

Additional information received indicated that the patient underwent surgical intervention on (b)(6) 2020 wherein the ipg was explanted and replaced.Reportedly, effective therapy was established.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10491917
• MDR Text Key: 205673754
• Report Number: 1627487-2020-31062
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7413679
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 1192; MODEL 3186 (X2)
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 129