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); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.Concomitant medical products: model: 3662, scs ipg - therapy date unknown.Model: 3186, scs lead (2) - therapy date unknown.Model: 1192, scs anchor - therapy date unknown.

Event Description

Related manufacturer reference numbers: 3006705815-2019-02199, 3006705815-2019-02200, 3006705815-2019-02201, 1627487-2019-07017.It was reported that patient experienced mild redness, warmth, and tenderness with palpation around the ipg site.There was also minimal clear drainage at ipg incision site and the lead incision site.On (b)(6) 2019, the incision sites were cleaned, steri strips were applied, and antibiotics were administered.The drainage resolved at both incision sites.

Manufacturer Narrative

The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.During processing of this complaint, attempts were made to obtain patient weight, but it was not received.

Event Description

Related manufacturer reference numbers: 3006705815-2019-02199.3006705815-2019-02200.3006705815-2019-02201.1627487-2019-07017.It was reported that the patient's infection and related medical issues have resolved with antibiotics under the care of a physician.

• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8704194
• MDR Text Key: 148176363
• Report Number: 1627487-2019-07016
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Model Number: 1192
• Device Lot Number: 6840023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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