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

Model Number 1192

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 3006705815-2020-01716, 3006705815-2020-02924, 3006705815-2020-02925, 1627487-2020-23066.It was reported that while the physician went in to replace the ipg, the physician found infection at the ipg and lead site and decided to explant the 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. .

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SWIFT-LOCK ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10314962
• MDR Text Key: 200077886
• Report Number: 1627487-2020-23065
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6510040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL # 1192 - ANCHOR; MODEL # 3772 - IPG; MODEL 3186 - LEAD (X2); MODEL # 1192 - ANCHOR; MODEL # 3772 - IPG; MODEL 3186 - LEAD (X2)
• Patient Outcome(s): Other
• Patient Weight: 98