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

Model Number 1192

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

Patient Problem Skin Erosion (2075)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.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

Related manufacturer reference number: 3006705815-2020-02256, 3006705815-2020-02258.Related manufacturer reference number: 1627487-2020-21670.It was reported the patient had a lead popping through the incision.Surgical intervention took place where the system was explanted to address the issue.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SWIFT LOCK 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10150434
• MDR Text Key: 195021034
• Report Number: 1627487-2020-21669
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7330765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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 # 1192 - ANCHOR; MODEL # 3186 - LEAD (X2)
• Patient Outcome(s): Other
• Patient Weight: 91