MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 60CM; SCS LEAD

Model Number 3386

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 4 of 5.Mfr report # 1627487-2018-01152, 1627487-2018-01150, 1627487-2018-01151, 1627487-2018-01154.It was reported that patient had developed an infection that was not healing.As a result, patient underwent a surgical intervention on an unknown date wherein pns stimulator system was explanted.

Event Description

Device 4 of 5.Mfr report # 1627487-2018-01152, 1627487-2018-01150, 1627487-2018-01151, 1627487-2018-01154.Additional information revealed that patient stated that explant happened around autumn of 2017.

Event Description

Device 4 of 5.Mfr report # 1627487-2018-01152, 1627487-2018-01150, 1627487-2018-01151, 1627487-2018-01154.Additional information revealed that patient¿s infection began post operatively and at the suture site of the lead.Symptoms started with redness and eventually incision site opened.Company representative was informed that it was a staphylococcus infection.Patient is being treated with antibiotic and was hospitalized twice during the course of treatment.

Event Description

Device 4 of 5.Mfr report # 1627487-2018-01152, 1627487-2018-01150, 1627487-2018-01151, 1627487-2018-01154.Additional follow up revealed that infection has resolved.

• Brand Name: EXTENSION, 60CM
• Type of Device: SCS LEAD
• 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
• MDR Report Key: 7252544
• MDR Text Key: 99374999
• Report Number: 1627487-2018-01153
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2016
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Device Lot Number: 4855395
• Other Device ID Number: 05414734402330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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): Hospitalization; Other
• Patient Age: 50 YR