MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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.Manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported the patient experienced a stitch protruding out of the skin.The patient was instructed to go to the emergency room.As a result, the emergency room physician removed the stitch and re-stitched the current area.Effective therapy was achieved.The patient returned to the emergency room, and the physician discovered an infection located at the lead site.Medical intervention may occur later to address the issue.

Event Description

Additional information received, identified the patient underwent surgical intervention wherein the scs system was explanted.Reportedly the patient was being monitored by physician.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: falon whitfield ; 6901 preston road; plano, TX 75024 ; 9725268233
• MDR Report Key: 7832694
• MDR Text Key: 118757458
• Report Number: 3006705815-2018-02090
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: 3186
• Device Lot Number: A000058131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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 3662, SCS IPG
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 98