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); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 6 of 6: reference mfr.Report: 1627487-2019-06491.Reference mfr.Report: 1627487-2019-06492.Reference mfr.Report: 1627487-2019-06493.Reference mfr.Report: 1627487-2019-06494.Reference mfr.Report: 1627487-2019-06582.It was reported the patient¿s wound at the tunneling incision point split open.To address the issue, the physician performed a wound debriding, wash out, and reclosed the wound on (b)(6) 2019.At the time of the debriding, the physician noted localized erythema and purulent discharge.Wound cultures were taken, but the results are not known at this time.The patient was prescribed antibiotics.It is unknown which two extensions are associated with this system, therefore all four extensions are being reported.

Event Description

Device 6 of 6.Reference mfr.Report: 1627487-2019-06491.Reference mfr.Report: 1627487-2019-06492.Reference mfr.Report: 1627487-2019-06493.Reference mfr.Report: 1627487-2019-06494.Reference mfr.Report: 1627487-2019-06582.Follow up information identified the patient has responded well to the antibiotics and the wound is healing as expected.Culture results remain unknown at this time.

Manufacturer Narrative

A case of wound issue-physician washed out and reclosed wound was reported to abbott.The patient appears to be responding well to antibiotics and the wound is healing as expected at this stage.Patient has effective therapy.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.

Event Description

Device 6 of 6; reference mfr.Report: 1627487-2019-06491, reference mfr.Report: 1627487-2019-06492, reference mfr.Report: 1627487-2019-06493, reference mfr.Report: 1627487-2019-06494, reference mfr.Report: 1627487-2019-06582.

• 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: 8670140
• MDR Text Key: 147041574
• Report Number: 1627487-2019-06583
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K960728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: 3383
• Device Lot Number: 6464688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2018
• 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: SCS EXTENSION (X3); SCS LEAD (X2)
• Patient Outcome(s): Other