MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

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

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2019-05934, related manufacturer reference number: 1627487-2019-05935, related manufacturer reference number: 1627487-2019-05938, related manufacturer reference number: 1627487-2019-05939, related manufacturer reference number: 1627487-2019-05941, related manufacturer reference number: 1627487-2019-05945.It was reported that the patient had two small openings and drainage at the midline and ipg incisions.As a result, the patient's system was explanted on (b)(6) 2019.The patient is currently healing from the procedure.

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.

Event Description

Related manufacturer reference number: 1627487-2019-05934; related manufacturer reference number: 1627487-2019-05935; related manufacturer reference number: 1627487-2019-05938; related manufacturer reference number: 1627487-2019-05939; related manufacturer reference number: 1627487-2019-05941; related manufacturer reference number: 1627487-2019-05945.It was reported that the patient's infection has cleared.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• 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: 8628015
• MDR Text Key: 145645991
• Report Number: 1627487-2019-05937
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 3383
• Device Lot Number: 6004703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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: 1192 X 2, SCS ANCHOR; 3186 X 2, SCS LEAD; 3383, SCS EXTENSION; 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 99